STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM +5 OFFSET; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 6260-9-236 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Ambulation Difficulties (2544)
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Event Date 02/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.H3 other text : device not returned.
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Event Description
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It was reported by claimant's counsel that allegedly the patient underwent right total hip arthroplasty on (b)(6) 2010, and was implanted with an lfit v40 femoral head and accolade tmzf stem.He underwent revision surgery on (b)(6) 2022, due to alleged dissociation of the femoral head from the trunnion.
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Search Alerts/Recalls
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