—#165169

Product

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

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K042515
Affected lot / code info: All lots

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

The Field Safety Notice (FSN) sent to risk managers on 06/13/2018 asks customers to inspect inventory, locate and quarantine affected, unused Journey BCS Knee CoCr Femoral Components and JOURNEY BCS OXINIUM Knee Femoral Components. Affected product subject of the voluntary removal is to be returned to Smith & Nephew. All consignees are asked to complete an FSN Response Form, even if they do not have product to return. The Field Safety Notice, communicated with surgeons that these first generation JOURNEY BCS tibial inserts should only be used for polyethylene exchange revision of the first generation JOURNEY BCS total knee constructs where the femoral component and tibial baseplate are well-fixed. This notification, addressed to implanting surgeons, requesting their receipt and acknowledgement of the FSN.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-06-13
Posted by FDA: 2018-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165169. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.