STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 6260-9-240 |
Device Problem
Material Erosion (1214)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/14/2021 |
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 (b)(6) 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 patient's attorney that allegedly the patient underwent bilateral hip arthroplasty on (b)(6) 2010, and was implanted with accolade tmzf hip stems and lfit v40 femoral heads.It is further alleged the right hip was revised on (b)(6) 2021 and during revision it was noted that the trunnion had been filed down to a point like structure based on the movement of the head around the proximal femur.
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Search Alerts/Recalls
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