STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Model Number 6260-9-236 |
Device Problem
Material Erosion (1214)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 03/29/2021 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.
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Event Description
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It was reported by the patient's attorney that allegedly on (b)(6) 2011, the patient underwent right total hip arthroplasty and was implanted with an lfit cocr v40 femoral head and a accolade tmzf hip stem.It is further alleged the patient was revised on (b)(6) 2021, due to elevated cobalt and chromium levels and pain in the right hip.
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Search Alerts/Recalls
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