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FDA-Device2018-10-10Class IIPROCESSING DEFECT

Smith & Nephew Journey BCS knee implant recalled for higher-than-expected revision rates

Smith & Nephew
OTHERNationwide distribution

Contact your surgeon about Smith & Nephew knee implant

Smith & Nephew's first-generation Journey BCS Knee System has shown a revision rate (need for replacement surgery) that is over 1.5 times higher than the average for similar knee implants, based on data from medical registries in the UK, Australia, and other countries. The implant is used in knee replacement surgery.

  • If you received this implant, contact your orthopedic surgeon to discuss whether monitoring or follow-up care is needed
  • Ask your surgeon about your specific implant model and what symptoms to watch for
  • Keep all follow-up appointments with your surgeon
Hazard

The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) 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.

Sold states
Worldwide distribution, including US nationwide and Puerto Rico, Austria, United Arab Emirates, Australia, Belgium, Canada, China, Switzerland, Germany, Denmark, Finland, France, Great Britain, India, Spain, Italy, Netherlands, Portugal, Sweden, Venezuela, South Africa.
Affected count
10,792 units
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2019

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