smith & nephew journey knee recall

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Smith & Nephew’s Knee Replacement Device Recalled

Written by Emre Ertugrul

Smith & Nephew’s first-generation knee replacement device was recalled on Oct. 1 as the Food and Drug Administration announced the Class 2 device recall online, following a series of research and tests regarding the high failure rate of the device.

Smith & Nephew’s JOURNEY Bi-Cruciate Stabilized (BCS) Knee system was the first-generation version of the JOURNEY II BCS which replaced the former on global market.

The Field Safety Notice (FSN) sent to risk managers on June 13, requested customers to inspect and locate the affected devices with the purpose of their returns to Smith & Nephew, the FDA stated in the report. The same notification was also sent to surgeons.

Earlier in June, Smith & Nephew issued a safety notice regarding the high rate of failure of its first-generation device, due to early femoral and tibial insert component complications.

Total knee replacement is the process in which part of the knee joint is replaced with artificial knee parts – a common process that is experienced by hundreds of thousands of Americans each year.

“Review of post-market surveillance data” resulted in the urgent safety notice as the device reportedly caused unexpectedly earlier needs in patients for painful revision surgeries. The manufacturer stated that JOURNEY BCS device had the same reasons for revision as other knee systems on the market, however, the first-generation device had “a rate higher than expected.”

The first-generation system was released for market globally in 2013 and is no longer for sale.

In August, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK issued a warning for providers and physicians that Smith & Nephew’s first-generation device has a 50% greater risk to cause early failure.

A clinical follow-up process conducted by Smith & Nephew concluded that the JOURNEY BCS Knee system has a revision rate over 1.5 times the average revision rates in the National Joint Registry of the UK and Australian Orthopaedic Association National Joint Replacement Registry.

The Journey II BCS Knee system will not be affected by the action.

Emre Ertugrul​

Emre Ertugrul is a reporter for Safetywatch.org, covering controversial drugs and medical devices, reporting on health policy and the FDA. He studied journalism with concentration in investigative reporting at Boston University. Previous experience with the New England Center for Investigative Reporting include tax issues, racial profiling and criminal justice. He also worked as an international news intern at Milliyet Newspaper and is currently one of the editors for Gazet.com.

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Smith & Nephew Journey BCS Knee Replacement

Your first generation Smith & Nephew Journey Bi-cruciate Stabilized (BCS) Knee replacement system (Journey I BCS Knee System) may be defective. The manufacturer issued a voluntary recall in June of 2018, but phased this model out of production five years ago. If you had a first generation Smith & Nephew Journey BCS knee implanted, and the product failed, you may be entitled to compensation.

We are no longer accepting new cases.

How Weitz & Luxenberg Can Help

Weitz & Luxenberg is currently accepting clients who received a first generation Smith & Nephew Journey BCS knee and subsequently needed to undergo a revision, or replacement, surgery or have been advised by their doctor they need to undergo a revision surgery due to femoral component loosening. We invite you to contact us for more information about your legal options.

If you have undergone a knee replacement surgery, are having problems, and are not sure whether you received a first generation Smith & Nephew Journey BCS knee, we encourage you to ask your doctor which knee replacement model you received. Depending on your specific implant, you may be able to seek compensation.

First Generation Journey BCS Knee Complications

Revision surgeries are costly. You may also need to undergo follow-up treatment and physical therapy.

You may not be able to earn a living if your knee complications keep you disabled at home. Your total medical costs could become exorbitant.

Possible first generation Smith & Nephew Journey BCS knee implant complications for which you could receive compensation may include:

• Recommendation from your physician to undergo a revision surgery due to femoral component loosening.
• Revision surgery due to femoral component loosening.

Knee Implant Recall

Smith & Nephew voluntarily recalled its first generation Journey BCS Knee System on June 13, 2018. The U.S. Food and Drug Administration later categorized this recall as Class 2. (1) (2)

The manufacturer indicated in its Urgent Field Safety Notice that this knee was failing as a higher rate than other primary total knee arthroplasty implants. It noted that data in two joint registries “indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.” (3) (4) (5)

In its Urgent Field Safety Notice Smith & Nephew asked customers to inspect inventory and locate and quarantine affected, unused devices. (6) (7) (8)

Field Safety Notice

In its Urgent Field Safety Notice, Smith & Nephew said the affected product was its first-generation Journey BCS, which was introduced to the market in 2005. The company phased this model out of production between 2013 and 2014. (9) (10)

Smith & Nephew said its “analysis of available post-market surveillance data suggests that patients that have been implanted with a first generation JOURNEY BCS Knee System may have a higher risk of requiring a revision earlier than they or their surgeon had expected.” (11) (12)

Design Failure

On July 23, 2018, the United Kingdom issued a medical device alert instructing against implanting Smith & Nephew’s first generation Journey BCS knee device and cautioned physicians to monitor patients regularly for up to 10 years for signs of device loosening. (13) (14)

In addition, the U.K.’s medical device alert notes the National Joint Registry of England, Wales, and Northern Ireland showed the revision rate for this knee device was more than double the average rate for primary total knee replacements. (15) (16)

What Studies Show

According to authors of one study partially funded by Smith & Nephew, Smith & Nephew’s first generation Journey BCS had a significantly higher rate of revision than Smith & Nephew’s Journey II knee. The Journey I had a risk of revision over four times higher than the Journey II. (17) (18)

Hear From Our Clients

I chose Weitz & Luxenberg because the firm has a reputation for working really hard. I went with them because I didn’t want just anybody representing me. I felt that, if I was going to sue, I wanted a firm that had a lot of experience and a lot of resources. I wanted the big guns.”

Implant Litigation

Weitz & Luxenberg has been litigating cases involving defective medical devices for decades. As a national firm, we are prepared to handle large-scale medical device litigation across the country.

Our attorneys make it their mission to help clients harmed by defective medical products any medical device corporations create and promote. They are specially trained to handle complex medical device lawsuits.

If you were implanted with a defective knee replacement, we may be able to seek appropriate compensation on your behalf. Over the years, we have secured millions of dollars on behalf of clients injured by faulty medical devices.

For more information, we encourage you to contact us at (833) 977-3437 .

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• U.S. Food & Drug Administration. (2018, October 1). Class 2 Device Recall. Journey BCS Knee System. Retrieved from https://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfres/res.cfm?id=165170
• U.S. Food & Drug Administration. (2018, October 1). Class 2 Device Recall. Journey BCS Knee System. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165169
• MHRA. (2018, June 13). Smith & Nephew. Urgent Field Safety Notice. Retrieved from https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202018/3-7-2018/JOURNEYIIBCSKneeSystem.pdf
• Smith & Nephew, Inc. (2018, June 13). Urgent Field Safety Notice. Retrieved from https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202018/3-7-2018/JOURNEYIIBCSKneeSystem.pdf
• Eisner, W. (2018, August 8). Safety Notice for S&N Journey BSC Knee. Retrieved from https://ryortho.com/breaking/safety-notice-for-sn-journey-bsc-knee/
• GOV.UK. (2018, July 23). First generation JOURNEY BCS Knee System—Higher than expected risk of revision (MDA/2018/026). Retrieved from https://web.archive.org/web/20180816121155/https://www.gov.uk/drug-device-alerts/first-generation-journey-bcs-knee-system-higher-than-expected-risk-of-revision-mda-2018-026
• Christen, B., & Kopjar, B. (2018, August 25). Second-generation bi-cruciate stabilized total knee system has a lower reoperation and revision rate than its predecessor. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/30167859

Device Recall Information

Medical device recalls.

MARCQI posts Class I and Class II recalls that involve implantable devices because of the risk to patients. For reference, the definitions of these classes, according to the Food and Drug Administration (FDA), are:

• Class 1 recall:   a situation in which there is a reasonable probability that the use of or exposure to a volatile product will cause serious adverse health consequences or death.
• Class 2 recall:  a situation in which use of or exposure to a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class 3 recall:  a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
• Medical Device Safety Alert:  issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
• Correction or Removal:  manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.

2020 Class I Recalls (updated 3/17/2023)

September 2020

Recall #  Z-2941-2020

• MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation

2024 Class II Recalls (updated 6/19/2024)

Recall # Z-1265-2024  

• NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM, Catalog number 5537-G-416-E, Potential packaging breaches of inner blister and outer sterile blister.

Recall # Z-1625-2024

• TRIDENTII HEMI CLUSTER54E, Catalog number 702-11-54E – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Recall # Z-1624-2024

• TRIDENTII HEMI CLUSTER52E, Catalog number 702-11-52E – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.

Recall # Z-1622-2024  

• TRIDENTII HEMI CLUSTER48D, Catalog number 702-11-48D – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.

Recall #  Z-1260-2024   

• Triathlon Total Knee System, X3 TRIATHLON CS INSERT NO 6 10 MM – The reason for the recall is potential packaging breaches of the inner blister and outer sterile blister

Recall # Z-1298-2024  

• SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented – Due to two complaints, additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Recall # Z-1297-2024  

• SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented – Due to two complaints, additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Recall # Z-1296-2024  

• SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented – Due to two complaints, additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

2023 Class II Recalls (updated 11/28/2023)

November 2023

Recall # Z-0214-2024  

• Unity Total Knee System, Model Number 112.001.34.- Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labeled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

Recall # Z-0213-2024  

• Unity CR Femur Right, Size 6, Model Number 112.001.32 – Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labeled as Unity CR Inserts Right size 7 from batch 532405 and visa versa

Recall #  Z-0158-2024  

• JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis – The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. Also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled, and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

Recall # Z-0157-2024  

• JOURNEY  II BCS Articular Insert REF 74027262; knee prosthesis- The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled, and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. Also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled, and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM

October 2023

Recall # Z-2519-2023  

• Zimmer – M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 and Size 6 – Reason for recall is mixed-up of materials/components. The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

Recall # Z-1673-2023  

• ENGAGE Cementless Partial Knee System, Coated Tibial Insert- Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

Recall # Z-1672-2023  

• ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL- Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

Recall #  Z-1671-2023  

• Smith & Nephew – ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prosthesis- Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

Recall # Z-1670-2023  

• Smith & Nephew – ENGAGE Cementless Partial Knee System, Porous Femoral components, various sizes- Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

Recall # Z-1393-2023    

• JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

Recall # Z-1294-2023  

• CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384 received an Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard 

Recall # Z-1284-2023

• G7 Acetabular System, Dual Mobility Acetabular Liner, 40mm, Size D, Model # 110024462 has an outer package where the labeling and product etch are a 40mm Site D liner, however, the implant is a 38mm Size C liner

Recall # Z-1263-2023 , Z-1264-2023 , Z-1265-2023 , Z-1266-2023 , Z-1267-2023

• Attune Revision Tibial Insert (various sizes) received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties

Recall # Z-1733-2022 , Z-1732-2022 , Z-1731-2022 , Z-1730-2022 , Z-1734-2022 , Z-1728-2022 , Z-1727-2022 , Z-1726-2022, Z-1729-2022

• Specific GLX acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear

Recall # Z-1850-2021 , Z-1851-2021

• Corin TriFit has units from one batch where TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.

Recall # Z-1509-2022

• Corin METAFIX size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630

Recall # Z-1725-2022 , Z-1726-2022 , Z-1727-2022

Recall # Z-0007-2023

• G7 Acetabular System, Acetabular Shell has outer sterile package cavity with a corner wall thickness that is below the specification. this corner wall could potentially crack during transit. potential risks include non-clinically or clinically significant extension of surgery or infection leading to surgical intervention

Recall # Z-0275-2023 , Z-0276-2023

• Evolution MP Tibial Bases, various sizes has 1 confirmed incident where ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgers and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging

Recall # Z-0273-2023

• The Utility Total Knee System’s internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging

Recall # Z-0466-2023 , Z-0467-2023 , Z-0468-2023 , Z-0469-2023 , Z-0470-2023 , Z-0471-2023

• Nextgen option stemmed tibial component, various sizes, has clinically and statistically significant higher overall revision rates when these tibial components are used with either the legacy posterior stabilized flex or LPS flex gender solutions femoral components as compared to other total knee arthroplasties in the United Kingdom National joint registry

Recall # Z-0951-2023

• Biostop F Bioresorbable Cement Restrictor is being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance…endotoxins have a potental to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs

Recall # Z-0726-2023 , Z-0727-2023

• Corin BIOLOX Delta Mod Head size 36xl is labelled as the size 32xl and vice-versa

2022 Class II Recalls (updated 3/18/2022)

Recall # Z-0670-2022

• Acos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength

2021 Class II Recalls

November 2021

Recall # Z-0160-2022 , Z-0159-2022

• Limacorporate S.P.A. Bone Screw/ Vite, various sizes, has a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included

September 2021

Recall # Z-2515-2021 , Z-2514-2021 , Z-2509-2021 , Z-2510-2021 , Z-2511-2021 , Z-2512-2021 , Z-2513-2021

• Univation X System knee implant devices could malfunction, loosening the implant resulting in a potential revision surgery

Recall # Z-2348-2021

• Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

August 2021

Recall #s Z-2264-2021 , Z-2275-2021 , Z-2265-2021 , Z-2264-2021 , Z-2263-2021 , Z-2262-2021 , Z-2266-2021 , Z-2271-2021 , Z-2272-2021 , Z-2270-2021

• Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

Recall #s Z-2273-2021 , Z-2269-2021 , Z-2268-2021 , Z-2267-2021 , Z-2261-2021 , Z-2262-2021 , Z-2260-2021 , Z-2259-2021 , Z-2274-2021

• o Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

Recall #s Z-2250-2021 , and Z-2251-2021

• o Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 10-36-03 (36mm +3.5)

Recall #s Z-2242-2021

• The nail head may become detached during surgery.

Recall #s Z-2133-2021 , Z-2132-2021 , Z-2115-2021 , Z-2116-2021 , Z-2117-2021 , Z-2118-2021 , Z-2119-2021 , Z-2120-2021 , Z-2121-2021 , Z-2122-2021 , Z-2123-2021 , Z-2124-2021 , Z-2126-2021 , Z-2127-2021 , Z-2128-2021 , Z-2129-2021

• Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning

Recall # Z-2107-2021

• Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch

Recall # Z-2774-2020

• Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

Recall # Z-0118-2021

• The anterior locking detail does not meet its design specifications.

Recall #s Z-2331-2020 , Z-2332-2020 , Z-2333-2020 , Z-2334-2020 , Z-2335-2020 , Z-2336-2020

• A manufacturing error resulted in out of specification R3 Acetabular Shells

February 2021

Recall # Z-0802-2021

• Certain Pinnacle Cup devices may potentially exhibit an oversized “minor diameter”, which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of “cross-threading”. If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.

2020 Class II Recalls

November 2020

Recall # Z-0332-2021

• Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions

Recall # Z-0344-2021

October 2020

Recall # Z-0057-2021

• The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm

Recall # Z-0081-2021

• Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

Recall # Z-0097-2021

• RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930
• RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750
• The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.

August 2020

Recall # Z-2948-2020

• MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR¿ Hip System Package Insert with the most recent revision (150803-8)

Recall # Z-2849-2020

• Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920

Recall # Z-2145-2020

• Potential presence of elevated endotoxin levels that exceed the specification limit

Recall # Z-2146-2020

Recall # Z-2147-2020

Recall # Z-2149-2020

Recall # Z-2150-2020

• 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM
• 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM
• 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM

Recall # Z-2151-2020

• 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM
• 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM
• 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM
• 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM

Recall # Z-2152-2020

Recall # Z-2153-2020

Recall # Z-2154-2020

• Zimmer Biomet- Knee Products:

1) 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 2) 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM

Recall # Z-2155-2020

Recall # Z-2156-2020

Recall # Z-1478-2020

• Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging

Recall # Z-1479-2020

Recall # Z-1480-2020

Recall #: Z-1481-2020

• Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

Recall # Z-1482-2020

2019 Class II Recalls

• Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 20mm screws to be packaged as 30mm screws and vice versa.
• Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.

2018 Correction or Removal

• Zimmer M/L Taper Hip Prosthesis, 7711 Series, Fem Stem 12/14 Neck  Taper, Sz 4
• Zimmer M/L Taper Hip Prosthesis, 7711 Series, Fem Stem 12/14 Neck Taper, Sz 7.5

2018 Class 2 Recalls

• The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
• Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa.
• One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray.
• Error in labeling. The labeling of the implant box outer label states the correct size of the implant. The patient sticker located inside the outer box states the incorrect size of the implant.
• There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
• Zimmer Ringloc CoCr Modular Femoral Heads -6mm offset
• Zimmer Vanguard CR Porous Femoral 32.5mm LT Femur
• Depuy SIGMA HP PFJ Cemented Trochlear Implant
• Zimmer Biomet VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
• Zimmer Biomet VERSYS 10 INCH BEADED FC REV 15.0X250MM BOWED LT & RT
• Zimmer Biomet VERSYS 10 INCH BEADED FC REV 13.5X250MM BOWED LT and RT
• Zimmer Biomet VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT
• Zimmer Biomet VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK
• Zimmer Biomet VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK
• Zimmer Biomet VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK
• Zimmer Biomet VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK
• Zimmer Biomet CPT 12/14 COCR, SIZE 0, STD
• Zimmer Biomet CPT 12/14 COCR REVISION SIZE 2 180MM
• Zimmer Biomet CPT 12/14 COCR SIZE 1 EXT
• Zimmer Biomet CPT 12/14 COCR Sz 2 Multiple Lot Numbers
• Zimmer Biomet CPT 12_14 COCR Sz 2 STD Multiple Lot Numbers
• Zimmer Biomet BIPOLAR METAL SHELL 48 MM OD
• Zimmer Biomet CPT 12/14 COCR SIZE 2 EXT
• Zimmer Biomet NEXGEN POROUS, HA/TCP, UNCEMENTED FEM & TIB BASEPLATE, SZ C thru G, LT & RT, MINUS
• Zimmer Biomet Nexgen Porous, HA/TCP, Uncemented Fem & Tib Baseplate, SZ C thru G, LT & RT, MINUS, MULTIPLE CAT #S
• Zimmer Biomet NEXGEN POROUS, UNCEMENTED FEMORAL AND TIB BASEPLATE, SZ E & F, LT
• Zimmer Biomet NEXGEN POROUS, HA_TCP, UNCEMENTED FEM & TIB BASEPLATE, SZ C thru G, LT&RT
• Zimmer NexGen LPS Option Fem Comps Sz C thru H
• Zimmer NexGen LPS Fem Comp Sz B thru G
• Zimmer NexGen LPS Fem Comp Sz G, Left
• Zimmer NexGen LPS Precoat Femoral Sz D & E
• Zimmer NEXGEN LPS Flex Precoat Fem Comp, Sz B thru G
• Zimmer NEXGEN LPS Flex Porous Fem Comp, Sz E
• Zimmer NexGen LPS Precoat Femoral Sizes D thru F
• Zimmer NexGen LPS Flex Option Fem Comp
• Zimmer NEXGEN LPS Flex GSF Option, SZ C thru G, LT & RT
• Zimmer NEXGEN LPS Flex GSF Porous Fem, SZ F, RT
• Zimmer NEXGEN CR Flex Option Femoral Minus, Sz C thru G
• Zimmer NEXGEN CR Flex Opt Femoral, Sz C thru G, LT & RT
• Zimmer NEXGEN CR Flex Porous Femoral
• Zimmer NexGen CR Flex GSF Precoat, SZ C thru G, LT & RT
• Zimmer The Natural Knee II Sys Cancellous Structured Titanium Porous Coating
• Zimmer Natural Knee Flex_NexGen CR Flex
• Zimmer Natural Knee Flex GSF NonPorous Fem
• Zimmer Natural Knee Flex GSF Porous Fem
• Zimmer NEXGEN Complete Knee Solution Legacy Posterior Stabilized, Sz H-Right
• Zimmer NEXGEN Complete Knee Solution Legacy Posterior Stabilized, LCCK, Sz C thru F
• Zimmer NEXGEN Complete Knee System Precoat Fem Comp
• Zimmer NEXGEN Knee System CR Option Fem Comp
• Zimmer NEXGEN Complete Knee Solution CR
• Zimmer NEXGEN Knee, SZ 4 thru 8, LT AND RT
• Zimmer PFJ Fem Cemented
• Zimmer PFJ Fem Cemented, SZ 4, RT
• Zimmer Unicomp Knee, SZ B thru F, RT & LT, MED & LAT
• Zimmer Unicomp Knee, RT and LT, SM, REG and LGE
• Zimmer Biomet Versys 6 inch Beaded Full Coat Plus Hip Prosthesis, multiple Catalog Numbers and  Expiration Dates
• Zimmer Segmental System, ZSS Distal Femur, multiple Catalog Numbers and Expiration Dates
• DePuy Corail Coxa Vara HO Collared Stem,  Sz9, Part No. 3L93709
• Depuy Corail HO Collarless Stem, Sz14, Part No. L20314
• Exactech Alteon Femoral Stem Collared, Sz5, Catalog #190-30-05
• Zimmer G7 Dual Mobility Liner, F-44 mm, Item #110024464
• Zimmer AGC Porous Patellar, Med, Model #150804
• Zimmer AGC Patella Porous, SM, Model #150802
• Zimmer Vanguard CR Tibial Bearing, 12×71/75mm, Item #183442
• Zimmer Vanguard CR Lipped Tibial Bearing, 10×71/75mm, Item #183540
• Biolox Delta Option Ceramic Heads, 32MM, Model #650-1056
• Ceramic Option Type 1 Taper Sleeve, -6, Model #650-1064
• Echo Bimetric Porous Femoral Hip System, 9×125, Model #192009
• OSS Distal Femoral LT ASSY, 19CM,  Model #CP111828
• OSS Distal Femoral RT ASSY,  19CM,  Model #CP111817
• OSS Cemented IM Stem 12×150, Model #150366 
• Zimmer Biomet PPS RingLoc+ Acetabular Shell, SZ62, Model #11-116062
• Medacta GMK Knee System

2017 Class 2 Recalls

• An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection
• Repicci II Tibial Components
• Zimmer Biomet Custom Polyethlylene Implants
• Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
• Multiple products including Active Articulation, Biolox Delta Option Head, RingLoc

Field Safety Notice

• Biomet UK issued a voluntary field safety corrective action; analysis identified a world wide occurrence of 0.12% of patients experiencing tibial plateau fractures.
• In a small number of cases, cracks that occur in the welds of the head of the mallet have resulted in the escape of some lead beads.
• Vanguard Total Knee System
• Zimmer Biomet RingLoc ArComXL Highly Crosslinked Polyethylene Liners

Instruments

• Exactech Logic Fit Tibial Tamp Head
• Exactech 1.5” Novation Calcar Planer Guide Tip
• Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates (Zimmer Biomet)
• Stryker Instruments Precision Match Head , Precision Round, MIS (minimally invasive surgery) product to remove osseous material during surgical cases. Multiple sizes.
• Handle that is used to hold surgical components during acetabular reaming in MAKO Total Hip Procedures
• Five AFMEA Riskk Control Measures are missing from the User Guides.
• Vanguard Total Knee, Punch Thru TRL Plates, 63mm, 67mm, 71mm, 75mm, 79mm
• Oxford Knee System Tibial Resector Body Tube & Guides
• Oxford Knee System Femoral Slap Hammer
• Left Medial Tibial Trial Tray Size A
• Left Medial Tibial Trial Tray Size B
• Left Medial Tibial Trial Tray Size C
• Left Medial Tibial Trial Tray Size D
• Left Medial Tibial Trial Tray Size E
• Left Medial Tibial Trial Tray Size F
• Phase 3 Tibial Template L Medial Size B
• Phase 3 Tibial Template L Medial Size C
• Phase 3 Tibial Template R Medial Size A
• Phase 3 Tibial Template R Medial Size B
• Phase 3 Tibial Template R Medial Size C
• Phase 3 Tibial Template R Medial Size D
• Right Medial Tibial Trial Tray Size A
• Right Medial Tibial Trial Tray Size B
• Right Medial Tibial Trial Tray Size C
• Right Medial Tibial Trial Tray Size D
• Right Medial Tibial Trial Tray Size E
• Right Medial Tibial Trial Tray Size F
• Oxford Unicompartmental Knee Phase 3 Shim Size 1
• Oxford Unicompartmental Knee Phase 3 Shim Size 2
• Oxford Unicompartmental Knee Phase 3 Shim Size 3
• Oxford Unicompartmental Knee Phase 3 Tibial Impactor

2016 Class 1 Recalls

DuPuy Synthes Power Tool System Battery Adaptor

Greatbatch Medical Standard Offset Cup Impactor – Inadequate Sterilization

2016 Class 2 Recalls

Posted April, 2016

The following Class II Recall Notifications from Zimmer Biomet include a variety of catalog and lot numbers. The reason, cause, and action for each recall can be found in each of the .pdf documents listed here for your reference.  A link to the FDA website for each recall is also included at the bottom of each .pdf file.  Please review the details to determine any impact to your cases.

The reason, cause, and action for the recalls listed below is as described by the FDA on its website:

Manufacturer Reason for Recall

As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile.

FDA Determined Cause 2

Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:

• Review the notification and ensure that relevant personnel are aware of the contents.
• Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
• Your Zimmer Biomet sales representative will remove the recalled product from your facility.
• Complete and return the attached Certificate of Acknowledgment form to [email protected].
• If after reviewing this notification you have further questions or concerns please call

Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative

• Zimmer Packaging Recall
• NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3
• SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE

November, 2016

• Stryker LFIT Anatomic V40 Femoral Head

October, 2016

• Stryker Sagittal Blade 18.0X0.97X90MM
• Zimmer Gender Solutions  Patellofemoral Joint Prosthesis Milling Handpiece

September, 2016

• Stryker Orthopaedics Patella Assembly Instrument (Scorpio Patella Assembly)

August, 2016

• Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock
• (Stryker) Exeter Rasp/Trial Introducer/Extractor Handle part of the Exeter Femoral Hip System
• Stryker Orthopaedics Trident Constrainer Liner Inserter/Impactor Tip, 22mm, 28mm, and 32mm (sterilization issue)
• Zimmer Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets
• Prelude Patella Femoral Resurfacing Knee System Instrumentation
• Restoris PST Offset Shell Impactor
• Robotic Arm Interactive Orthopedic System (MAKO)

2015 Class 1 Recalls

Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks Higher than Expected Levels of Manufacturing Residues

Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree

2015 Class ll Recalls

LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery

LCS COMPLETE RPS inserts various sizes. Knee prosthesis component for orthopedic surgery

Stryker Trident 10 degrees x 3 Insert 36 MM

Stryker Triathlon x3 Tibial Bearing Insert

Stryker Triathlon PS x3 Tibial Insert, No 3 Triatholon TS Plus Tibial Insert x 3 Poly 19 mm

Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component

NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3

Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile

Instruments 

Stryker MIS Modular Distal Capture Triathlon MIS Instruments

SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades

Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland

ORTHOPAEDICS

Journey ◊ ii total knee arthroplasty.

Total knee arthroplasty patients report unmet levels of satisfaction, particularly for more active or demanding activities. 1,2 The JOURNEY II System is designed to help patients rediscover their normal through a smoother recovery, *3,4 improved function *4-8 and higher patient satisfaction *2,4-6

Normal shapes. Normal position. Normal motion

Reproduction of optimal kinematic patterns during TKA could be instrumental in improving patient satisfaction. 11 The solution to providing patients with better overall satisfaction and functionality is to design an implant as close to the normal knee as possible.

The JOURNEY II System has been shown to restore anatomical shape, position and motion. 9,10,12-14 This anatomical restoration can provide superior clinical outcomes that can lead to high patient satisfaction. *3-5,8,15

Product Features

Journey ii tka video: rediscover normal, show videos, reference materials, medical education, related products.

* Compared to non-JOURNEY II knees.

This design rationale is for informational and educational purposes only. It is not intended to serve as medical advice. It is the responsibility of treating physicians to determine and utilise the appropriate products and techniques according to their own clinical judgment for each of their patients.

For detailed product information, including indications for use, contraindications, effects, precautions and warnings, please consult the product’s Instructions for Use (IFU) prior to use.

• Scott CEH, et al. J Bone Joint Surg Am. 2010;92-B(9):1253-1258.
• Noble P.C, et al. Clin Orthop Relat Res 2012;470(1):20-32
• Mayman DJ, et al. Poster presented at: ISPOR Symposium;19-23 May, 2018; Baltimore, Maryland, USA
• Nodzo SR, et al. Techniques in Orthopaedics. 2018;33(1):37-41.
• Murakami K, et al. Int Orthop. 2018;42(11):2573-2581.
• Di Benedetto P, et al. Acta Biomed 2019; Vol. 90, Supplement 12: 91-97.
• Kosse NM, et al. Poster presented at: 2nd World Arthroplasty Congress;19-21 April, 2018; Rome, Italy.
• Takubo A, et al. J Knee Surg. 2017;30(7):725-729.
• Grieco T, et al. J Arthroplasty. 2018;33(2):565-571.
• Smith LA, et al. J Arthroplasty. 2021;36:1445-1454.
• Van Onsem S, et al. Clin Orthop Relat Res (2020) 478:255-263.
• Iriuchishima T, et al. J Knee Surg. 2018;31(6):568-572.
• Murakami K, et al. J Orthop. 2018;15(2):650-654.
• Carpenter RD, et al. Knee. 2009;16(5):332-336.
• Noble PC, et al. Clin Orthop Relat Res. 2005(431):157-165.
• Kaneko T, et al. J Orthop. 2017;14(1):201-206.
• Brilhault J, et al. Knee. 2010;17(2):148-151.
• Catani F, et al. J Orthop Res. 2009;27(12):1569-1575.
• Hyodo K, et al. Arthroplasty Today. 2020;6(3):338-342.
• Hada M, et al. Knee Surg Sports Traumatol Arthrosc. 2018;26(6):1709-1716.
• Smith+Nephew 2012. Internal report. JRN2 KneeSim Analysis Memo.

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Smith & Nephew Knee Lawsuit

Please visit our main knee lawsuits page to see which types of knee-related litigations we are currently accepting.

Did you receive a Smith & Nephew Journey™ I BCS Knee and are now facing, or have had, revision surgery? If so, and you are considering filing a Smith & Nephew Knee lawsuit, we may be able to help.

The first generation model of Smith & Nephew’s Bi-cruciate Stabilized (BCS) Knee replacement system—the Journey I BCS Knee System—has had a high failure rate due to femoral component loosening. If you were implanted with the Journey I BCS Knee and have had or been told you need revision surgery, you may be entitled to compensation.

Trustwell Law is accepting cases on behalf of patients who received a first generation Smith & Nephew Journey BCS Knee and have had or been told they need revision surgery. Contact us at 800-796-1636 or submit your case details online for a free consultation, and someone from our legal team will contact you shortly. You may be entitled to compensation.

Our attorneys have years of experience and a reputation for personalized, compassionate partnering with our clients. We also have access to the expertise, resources, and manpower to fully investigate your circumstances in order to get you the justice you deserve.

Smith & Nephew Journey I BCS Knee Replacements

The first-generation Smith & Nephew BCS Knee, the Journey I BCS Knee System, was first sold in 2005 for partial and total knee replacements. Marketing materials indicated the line was aimed at younger, more active patients. But the UK-based company began phasing out the Journey I model in 2013 and 2014. Following the Journey I, Smith & Nephew introduced the Journey II.

Smith & Nephew Journey I BCS Knee Recall

In June 2018, Smith & Nephew voluntarily issued a recall for the Journey I BCS Knee. In the Urgent Field Safety Notice the company released, it explains that the knee was found to have a revision rate one and a half times higher than similar knee implants. The company further stated that recipients of the device could need revision surgery earlier than they or their doctors would normally expect. The Notice also cautioned medical practitioners and facilities that had purchased the unit to find and set aside any unused devices.

The U.S. Food and Drug Administration (FDA) later classified this recall as a Class II recall: “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Smith & Nephew Journey I BCS Knee Replacement Issues and Warnings

In July 2018, the United Kingdom, where Smith & Nephew is based, issued a medical device alert concerning the Journey I BCS Knee replacement system. The alert instructed medical practitioners not to implant the Journey I BCS Knee, and it further advised physicians who had already implanted the device to monitor their patients carefully for up to ten years—to watch for signs of femoral component loosening and implant destabilization.

The alert related that the National Joint Registry of England, Wales, Northern Ireland, and the Isle of Man had found the revision rate of the Journey I BCS Knee to be more than double the average rate for primary total knee replacements. And yet another study, partially funded by Smith & Nephew, found the revision rate to be four times greater for the Journey I knee as that of Smith & Nephew’s next release—the Journey II.

Smith & Nephew Journey I BCS Revision Surgery and Litigation

Revision, or replacement, surgery is painful and costly. In addition, having endured the original surgery for the hope of improved quality of movement and life that lasts many years, it is particularly disheartening to have to face revision surgery long before it would normally be expected.

If you or a loved one received a Smith & Nephew Journey I BCS Knee and have had or been advised that you need revision surgery due to femoral component loosening, contact us . You may be entitled to compensation for pain and suffering, medical and other expenses and lost work.

• Christen, B., and B. Kopjar. (2018, August 25). Second-generation bi-cruciate stabilized total knee system has a lower reoperation and revision rate than its predecessor. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/30167859
• Eisner, W. (2018, August 8). Safety Notice for S&N Journey BSC Knee. Retrieved from https://ryortho.com/breaking/safety-notice-for-sn-journey-bsc-knee/
• GOV.UK. (2018, July 23). First generation JOURNEY BCS Knee System—Higher than expected risk of revision (MDA/2018/026). Retrieved from https://www.gov.uk/drug-device-alerts/first-generation-journey-bcs-knee-system-higher-than-expected-risk-of-revision-mda-2018-026
• MHRA. (2018, June 13). Smith & Nephew. Urgent Field Safety Notice. Retrieved from https://mhra.filecamp.com/public/file/3l5k-3don01i7
• Smith & Nephew, Inc. (2018, June 13). Urgent Field Safety Notice. Retrieved from https://www.mcgartland.com/wp-content/uploads/2018/07/Smith-Nephew-Field-Safety-Notice-Journey-BCS-Knee.pdf
• U.S. Food & Drug Administration. (2018, October 1). Class 2 Device Recall. Journey BCS Knee System. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165169
• U.S. Food & Drug Administration. (2014, July 31). Recalls Background and Definitions. Retrieved from https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions

Free Case Evaluation

You will never be charged a fee unless a recovery is made for you.

NEWS: Lawsuit Alleges Mirena IUD Caused Permanent Vision Issues Younger People with Hip and Knee Implants at Higher Risk of Revision Surgery, Study Shows Stealth Recall of Atrium C-Qur Mesh Occurring, According to Court Filing Bellwether Trial Selection Continues in IVC Filter MDL Lawsuit Claims Mirena IUD Caused Pseudotumor Cerebri, Necessitated Brain Shunt

Knee Replacements Overview

• Revision Surgery
• Knee Replacement Lawsuit
• Zimmer Knee Replacement
• File a Lawsuit
• Recall Information
• Hiring a Lawyer

Many candidates for knee replacement surgery are older patients who suffered from osteoarthritis prior to their surgery; however, there are other reasons for the surgery, such as rheumatoid arthritis, developmental abnormality, or obesity.  Repetitive activity can also wear away the knee joint, and an increasing number of younger patients have also received knee implants to repair joints damaged through sports or other activities.

Patients who have received replacement knees often report a new lease on life, and advances in biomedical research and engineering have helped an increasing number of people enjoy normal, active lifestyles.  A well-designed replacement knee, under optimal conditions, can be expected to last up to 20 years and allow for all (or almost all) of the activities that a normal, healthy adult would be able to enjoy.

In some cases, however, new knee replacement devices and techniques have not lived up to their advertised promise.  Defective or poorly designed knees can have serious side effects for a joint implant recipient, including pain, immobility, and even the need for premature revision surgery .  Many examples of knees implants have been subject to recall (either voluntarily by the manufacturer or, in a few cases, at the insistence of the FDA).

Patients who have suffered the consequences of a defective knee replacement often find that litigation is the best way to get compensation to allow them to pay their bills and deal with other financial ramifications of their failed knee implant.

Types of knee replacement surgery

The knee is a complex joint, the largest in the body, and includes the following components:

• The knee cap (patella)
• The lower end of the thigh bone (femur)
• The upper end of the shin bone (tibia)
• Cartilage between the components to protect them and facilitate smooth movement of the joint
• Disks (menisci) between the tibia and femur that act as “shock absorbers”
• Ligaments to hold the tibia and femur together

If all or part of the knee joint is worn or damaged, a doctor may perform knee replacement surgery, in which all or parts of the knee joint are replaced.

Types of knee surgery include:

• Total knee replacement (TKR or arthroplasty):  all parts of the knee joint are replaced with synthetic components, including metal implants where the diseased bones are replaced and plastic spacers to prevent wear and to allow for movement.
• Partial knee replacement : only parts of the knee joint are replaced.  This surgery is ideal for candidates who have damage or wear on only one part of the knee joint.  Recovery is faster; however, in some cases patients need further surgery or find that pain is not relieved to the extent that it needs to be.  Partial knee replacement surgery includes patellofemoral replacement (of the knee cap and femur compartment at the upper part of the knee joint); unicompartmental knee replacement (of the compartment on either side of the knee); or bicompartmental knee replacement, where two of three of these components are replaced.

Components of knee replacement surgery are manufactured by several companies , including Biomet Orthopedics, DePuy Orthopedics (a subsidiary of Johnson & Johnson), Smith & Nephew Orthopedics, Inc., Stryker Orthopedics, Wright Medical, and Zimmer Orthopedics .

Recent advances in knee surgery

Since the first modern knee replacement surgery was performed in 1968, surgeons and researchers have made many attempts to improve the techniques, materials, and technology that are involved to achieve greater success.

Some recent innovations in knee replacements include:

• Minimally invasive surgery :  this allows for smaller incisions and faster healing.  However, it also requires great skill and precision on the part of the surgeon and some have argued that lesser technicians risk poorer outcomes.
• Cement-less knees :  in traditional knee surgery, cement is used to bond the knee implants with the existing bones.  In some cases, the cement can break down, causing devise failure.  In cement-less knees, the bone naturally fuses with the implant.  However, some studies suggest that cement-less knees can pose device failure problems of their own.
• Mobile-bearing vs. fixed-bearing implants : some companies offer a plastic insert that is able to rotate and offer greater movement for a patient compared to a fixed-bearing implant, in which the plastic spacer is firmly connected to the metal component.
• Posterior cruciate ligament-retaining vs. -substituting implants :  in which the patient’s ligament is used rather than replaced to create greater stability.
• Gender-specific designs : tailored to the female anatomy for greater functionality. There has been some debate as to whether these gender-specific designs are effective.

Complications associated with knee replacement surgery

While knee replacement surgery can offer mobility and freedom for pain in many cases, potential complications can arise, including:

• debilitating pain
• swelling of joints
• damage to surrounding tissues, ligaments, or arteries
• nerve damage
• bone loss, irregular growth, or fracture
• unstable joints (dislocation or loosening)
• limited range of motion
• problems standing or walking
• blood clots, deep vein thrombosis, pulmonary embolism
• allergic reaction

In some cases, serious complications can require knee revision surgery , which can be expensive, painful, and inconvenient.  Patients who are older, are obese, or who have diabetes, have a higher risk of developing some of these complications.

Recalled or defective knees: FDA action and warnings

Although all joint replacement surgeries come with some risks, certain brands of knee implants have caused disproportionately high numbers of complications or device failures.  Many problems with knee replacement implants and other devices arise in part because of the FDA’s 501 (k) clearance process in which additional safety trials are not required for a model of a knee that is deemed “substantially similar” to a model that has already been approved.  Unfortunately, this process often results in dangerous devices that are not adequately tested entering the market ; thousands who receive them serve as unofficial test subjects.

Between 2003 and 2013, there have been a total of 709 recalls associated with replacement knee implants or associated components.  These recalls have involved 6 manufacturers; most have been class II recalls (with class I being the most and class III being the least serious).  Class II recalls, in the description of the FDA, involve “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Recalled knee implants and components reported to the FDA up to May of 2013:

• Biomet :  75 recalls (all class II).  Recalled models include the Vanguard PS Open Box Femoral Component (2007, mislabeling); the Vanguard DCM PS Plus Tibial Bearing (2008, incorrect sizing).  Also at issue in these and/or other recalls:  improper assembly; missing features.
• DePuy (a subsidiary of Johnson & Johnson): 477 recalls (4 class I; 470 class II; 3 class II).  Recalled models include the LCS Knee Implant-Meniscal bearing insert (2008, mislabeling); the LCS Duofix Femoral Component (an international recall, outside the U.S., for higher-than-normal revision rates, 2009); LPS Diaphyseal Sleeve (2013, potential fracture of sleeve which could lead to “loss of function or loss of limb, infection, compromised soft tissue or death,” according to the FDA).  The LPS Diaphyseal Sleeve recall was a class I recall, the most serious kind.  Also at issue in these and/or other recalls:  possible fracturing; sizing issues; mislabeled components; metal debris; assembly difficulties; incomplete seal.
• Smith & Nephew : 11 recalls (all class II).  Recalled models include:  Oxinium Genesis II and Oxinium Profix II knees (2003; pain, loosening of the devices, and resulting necessity for revision surgery, 2003); TC-PLUS, VKS, and RT-PLUS knees (levels of iron higher than what was listed on their labels, 2008); Uni Tibial Baseplate (components prone to breakage).
• Stryker : 118 recalls (1 class I; 95 class II; 22 class III).  Recalled models include:  EIUS Unicompartmental Knee Systems (2012, higher-than-normal revision rates).  Also at issue in these and/or other recalls:  damaged component; disassociation; mislabeled components; component size; early wear and delamination.  (Problems with early wear and delamination may lead to the need for revision surgery.)
• Wright : 4 recalls (class II): improper length; co-mingled parts
• Zimmer : 224 Zimmer knee recalls (223 class II; 1 class III).  Recalled models include: Zimmer NexGen Complete Knee Solution LPS Femoral Component and the Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component (manufacturing defect, FDA-issued recall, 2010); NexGen Complete Knee Solutions Minimally Invasive Surgery (MIS) Tibial Components, Locking Screw, and Stem Extensions (2010, component loosening requiring revision surgery, FDA-issued recall after a warning letter was sent 6 months earlier).  Also at issue in these and/or other recalls:  faulty design; mislabeled components; missing components; manufacturing issues; difficulty with “insert” (difficult to insert the implant, leading to damage of device); implant loosening; sterility issues

Medical studies concerning knee replacement

Medical studies have also raised doubts about the safety of some artificial knees.  For instance, serious questions were raised about Zimmer’s NexGen Flex models by Richard Berger (a consultant for Zimmer) and his colleague Craig Della Valle, who informed the company in 2006 that there were problems with the cement-less NexGen CR Flex Porous Femoral Component, namely the loosening of the device .

Berger and Della Valle presented their findings at the meeting of the American Association of Orthopaedic Surgeons in 2008.  They had found that 9 out of 108 patients experienced femoral loosening and pain necessitating revision surgery and loosening occurred in a total of 39 patients.  Another study found that over a period of 18 months, 38% of patients with the NexGen LPS Flex Total Knee system showed loosening, while 21% required revision surgery in less than two years .

Pending knee implant litigation

As patients suffer the consequences of knee implants that are, in some cases, inadequately tested and poorly designed, many have determined to take legal action.  Over 1,000 patients have sued Zimmer Orthopedics in particular and their complaints have been consolidated as part of a multidistrict litigation (MDL no. 2722) in the U.S. District Court for the North District of Illinois.

The first knee replacement lawsuits to go before a jury are slated to take place in 2015; although they will share a streamlined discovery process, each complaint will be heard individually and receive its own outcome.

• New York Times, Surgeon vs. Knee Maker: Who’s Rejecting Whom? http://www.nytimes.com/2010/06/20/business/20knee.html?pagewanted=all&_r=1&
• Journal of Bone and Joint Surgery, High incidence of loosening of the femoral component in legacy posterior stabilized-flex total knee replacement http://www.bjj.boneandjoint.org.uk/content/89-B/11/1457.full.pdf
• Journal of Bone and Joint Surgery, Comparison of a Standard and a Gender-Specific Posterior Cruciate Substituting High-Flexion Knee Prosthesis: A Prospective, Randomized Short Term Outcome Study, http://jbjs.org/article.aspx?articleid=5699  
• Consumer’s Union, A Summary of Knee Recalls http://safepatientproject.org/wordpress/wp-content/uploads/2013/09/Knee-Recall-Summary-final-9-9-13.pdf
• FDA, DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall - Taper Connection May Not Accommodate Physiologic Loads http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm340740.htm
• American Academy of Orthopaedic Surgeons, Partial Knee Replacement http://orthoinfo.aaos.org/topic.cfm?topic=A00585
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Texas Smith & Nephew Journey Knee Recall Lawyer

Home » Medical Devices » Texas Smith & Nephew Journey Knee Recall Lawyer

Smith & Nephew, a major British medical device manufacturer, has recalled the Journey knee replacement multiple times in the last few years. The problem is a defective femoral implant and/or tibial baseplate, which may fracture or fail prematurely. When this complication occurs, patients may develop extreme pain, instability, and need revision surgery.

Australian Health Officials Issue Journey BCS Recall

The Journey Bi-Cruciate Stabilized (BCS) knee replacement was recalled in Australia on January 6, 2014. Health officials with the Therapeutic Goods Administration (TGA) reviewed a national joint registry database and found unacceptable revision rates associated with the femoral implant / tibial baseplate combination:

• Revision surgery rate of 1.59 per 100 observed component years; compared to 0.72 rate for other total knee replacements.
• Yearly cumulative revision rate of 7% at five years, compared to 3.8% for other knee replacements.
• Reason for revision surgery was more likely to include patellofemoral pain, unspecified pain, and instability in the knee.

Class II Recall for Journey II Uni Tibial Baseplate

Approximately 40,000 Journey II Uni Tibial Baseplates have been recalled by the U.S. Food and Drug Administration (FDA) on March 3, 2010. The Class II recall was issued after Smith & Nephew began receiving complaints about defective baseplate breaking. This complication can cause severe pain, knee instability, and treatment involves revision surgery.

Journey Deuce Linked to High Failure Rate

The Smith & Nephew Journey Deuce knee replacement was associated with a 14% two-year failure-rate in a study published by the Journey of Arthroplasty in September 2011. One patient had a “catastrophically failed tibial baseplate.” Out of 36 cases, 31% of patients had poor results, and 53% said they would not repeat the surgery.

Symptoms of Knee Replacement Failure

• Knee pain or swelling
• Change in alignment of knee
• Loose or unstable knee
• Bone loss (osteolysis)
• Bone fracture
• Loss of knee flexibility or function
• Decreased walking ability
• Nerve damage
• Internal bleeding
• Blood clots
• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism (PE)

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Journey BCS Knee Lawsuit

Health authorities in Australia have recalled the Smith & Nephew Journey BCS knee replacement after linking it to a 7% five-year failure rate. If your defective knee implant caused pain, loosening, failure, or revision surgery, contact our lawyers regarding a Journey BCS knee lawsuit .

What You Can Do & How a Journey BCS Knee Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting Smith & Nephew Journey BCS knee replacement induced injury cases in all 50 states. If you or somebody you know was injured by a defective knee implant, you should contact our lawyers immediately for a free case consultation . Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Overview of the Journey BCS Knee

Smith & Nephew manufactures the Journey Bi-Cruciate Stabilized (BCS) Knee Replacement System , which was approved by the U.S. Food and Drug Administration (FDA) in August 2007. It is marketed to improve knee motion in men and women. It provides function for both the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL).

Australian Health Authorities Issue Journey BCS Knee Recall

In January 2014, the Australian Therapeutic Goods Administration (TGA) recalled the Smith & Nephew Journey BCS knee replacement. After reviewing a national registry of joint replacements, they found that the Journey BCS had double the risk of failure and revision surgery compared to other knee replacements:

• Journey BCS linked to a 7% yearly failure rate at five years , compared to 3.8% with other knee replacements.
• Journey BCS linked to revision surgery rate of 1.59 per 100 observed component years, compared to 0.72 for other knee implants.

What is the problem?

In the recall notification , the TGA warned that the femoral component of the Journey BCS may be defective:

“The femoral implant / tibial baseplate combination of the Journey BCS knee replacement system is having a higher than expected revision rate when compared to all other primary total knee replacements.”

Defective Knee Replacement Side Effects

Australian health officials noted that the reason for revision surgery with the Journey BCS included problems that are typical of other knee implants, but it was linked to a higher rate of revision surgery due to patellofemoral pain, unspecified pain, and instability.

Complications a defective knee implant may include:

• Pain, inflammation, swelling
• Loose or unstable knee
• Tissue and nerve damage
• Bone fracture
• Bone loss (osteolysis)
• Revision surgery
• Decreased mobility

Additional Resources

• Smith & Nephew Journey Knee Recall — Journey BCS, Journey II Uni Tibial Baseplate
• Journey BCS recall announcement – Australian Therapeutic Goods Administration (TGA)

Do I have a Journey BCS Knee Lawsuit?

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Class 2 Device Recall ENGAGE Cementless Partial Knee System

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