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Smith & Nephew Journey BCS Knee

Smith & Nephew issued a voluntary recall of the first-generation Journey Bi-cruciate Stabilized (BCS) knee system in 2018, years after Smith & Nephew phased the model out of distribution. The FDA classified the recall as a Class 2 recall of the device.

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Did you experience complications after a Smith & Nephew knee replacement?

Smith & Nephew’s first generation Journey BCS knee implant, used for total knee replacement surgery, has been recalled due to increased rate of failure. Smith & Nephew voluntarily recalled this model in June of 2018. The U.S. Food & Drug Administration (FDA) posted a Class 2 Recall for this device approximately 3½ months later. 1 2 3

Journey BCS Knee System Smith Phased Out

Based out of Memphis, Tennessee, Smith & Nephew’s orthopedics division manufactures orthopedic devices, including implants for joint replacement surgery. Its first generation Journey BCS knee implant device received 510(k) approval by the FDA in March 2005.

The company phased this model out of distribution in 2013 through 2014. In June, 2018 Smith & Nephew recalled the first generation Journey BCS knee implant, basing its decision on postmarket data indicating that patients who had been implanted with the Journey BCS knee system faced a greater risk of needing to undergo a revision, or replacement, surgery. 4 5

Design Defects

When a manufacturer recalls a medical device, the recall may be related to the device’s design. In the case of Smith & Nephew’s first generation Journey BCS knee system, the United Kingdom was concerned about the device’s loosening and in July 2018 recommended that physicians not implant the first generation Journey BCS knee system in patients 6 7

The UK government also advised physicians to keep an eye on patients regularly for up to a decade to ensure the device had not failed and monitor for signs of loosening. The UK government’s announcement regarding the higher than expected risk of revision stated the National Joint Registry of England, Wales, and Northern Ireland showed that the revision rate for the first generation Journey BCS knee system was “more than double the average rate for primary total knee replacements.” 8 9

Recall and Litigations

Patients implanted with a first generation Smith & Nephew Journey BCS knee system who have undergone a revision surgery, or have been advised a revision surgery is likely necessary, may be able to pursue compensation from the manufacturer for damages.

When it recalled its first generation Journey BCS knee system, Smith & Nephew notified consumers the rate of revision for the Journey BCS was 1.5 times higher than other comparable knees. 10 11 12 13

If you undergo a revision surgery, or been advised a revision surgery will likely be necessary due to loosening leading to device failure, you may want to contact a reputable personal injury law firm specializing in defective medical devices.

Journey Knee Problems and Complications

In June of 2018, Smith & Nephew sent out an urgent field safety notice to consumers. The company warned about issues with its first generation Journey BCS knee system. 14 15

The notice said that the Journey BCS knee “can lead to a higher rate of revisions than expected” and “post-market surveillance data” indicated that patients who receive a first generation Journey BCS knee system during their total knee replacement surgery were more likely to have revisions than those who had other primary total knee arthroplasties.16

Data from the National Joint Registry of England, Wales and Northern Ireland and the Australian Orthopaedic Association National Joint Replacement Registry “indicated a revision rate 1.5 times greater than the average total knee arthroplasty device revision rate.” 17 18

Failure Symptoms

Smith & Nephew’s first generation Journey BCS knee system appears to be prone to loosening. This knee replacement system may not provide the stability a person needs to perform everyday activities. 19

Loosening is a problem that may require revision surgery. Knee replacement failure symptoms include, but are not limited to: 20 21

  • Pain.
  • Stiffness.
  • Instability.
  • Limited range of motion.
  • Looseness.

Patients may want to seek legal guidance from a reputable law firm experienced in handling and winning cases involving defective medical devices.

Implant Components

The first generation Smith & Nephew’s Journey BCS knee system “has an asymmetric femoral component, a polyethylene insert replicating 3° of the tibial varus, with a medially concave shape and a laterally slightly convex shape.” 22

The manufacturer distributed its Journey BCS knee system worldwide. At the time of Smith & Nephew’s recall in June 2018, several tens of thousands of these devices had been available in commerce. 23 24 25

  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=165171
  4. Smith & Nephew. (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
  5. MHRA. (2018, June 13). Urgent Field Safety Notice. Retrieved from https://mhra.filecamp.com/public/file/3l5k-3don01i7
  6. Eisner, W. (2018, August 8). Safety Notice for S&N Journey BSC [sic] Knee. Retrieved from https://ryortho.com/breaking/safety-notice-for-sn-journey-bsc-knee/
  7. 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
  8. Eisner, W. (2018, August 8). Safety Notice for S&N Journey BSC [sic] Knee. Retrieved from https://ryortho.com/breaking/safety-notice-for-sn-journey-bsc-knee/
  9. 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
  10. 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
  11. 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
  12. 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=165171
  13. 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/pmc/articles/PMC6182702/
  14. Densford, F. (2018, July 24). Smith & Nephew warns on first-gen Journey BCS knee revision rate. Retrieved from https://www.massdevice.com/smith-nephew-warns-on-first-gen-journey-bcs-knee-revision-rate/
  15. Smith & Nephew. (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
  16. Densford, F. (2018, July 24). Smith & Nephew warns on first-gen Journey BCS knee revision rate. Retrieved from https://www.massdevice.com/smith-nephew-warns-on-first-gen-journey-bcs-knee-revision-rate/
  17. Ibid.
  18. Smith & Nephew. (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
  19. 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
  20. Rousseau, M.-A., et al. (2006, November 21). Early mechanical failure in total knee arthroplasty. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2219938/
  21. OrthInfo. (2015, May). Revision Total Knee Replacement. Retrieved from https://orthoinfo.aaos.org/en/treatment/revision-total-knee-replacement/
  22. 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/pmc/articles/PMC6182702/
  23. 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
  24. 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
  25. 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=165171