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.
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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.

Doctor examines knee

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)

For a free consultation and more information about your legal options, please contact us today.

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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)

Knee x-ray

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)

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 (800) 476-6070.

  1. 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
  2. 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
  3. 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
  4. MHRA. (2018, June 13). Smith & Nephew. Urgent Field Safety Notice. Retrieved from https://mhra.filecamp.com/public/file/3l5k-3don01i7
  5. 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
  6. 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
  7. MHRA. (2018, June 13). Smith & Nephew. Urgent Field Safety Notice. Retrieved from https://mhra.filecamp.com/public/file/3l5k-3don01i7
  8. 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
  9. 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
  10. MHRA. (2018, June 13). Smith & Nephew. Urgent Field Safety Notice. Retrieved from https://mhra.filecamp.com/public/file/3l5k-3don01i7
  11. 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
  12. MHRA. (2018, June 13). Smith & Nephew. Urgent Field Safety Notice. Retrieved from https://mhra.filecamp.com/public/file/3l5k-3don01i7
  13. 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/
  14. 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
  15. 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/
  16. 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
  17. 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
  18. MHRA. (2018, June 13). Smith & Nephew. Urgent Field Safety Notice. Retrieved from https://mhra.filecamp.com/public/file/3l5k-3don01i7

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