STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 6260-9-232 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/22/2022 |
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.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 required revision surgery on (b)(6) 2022, due to alleged head disassociation.
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