STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LFIT COCR V40 FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number UNK_JR |
Device Problem
Degraded (1153)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 01/18/2023 |
Event Type
Injury
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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) 2009, and was implanted with an lfit v40 femoral head.Subsequently she allegedly developed persistent pain, metallosis and pseudotumor that required revision surgery on (b)(6) 2023.
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Manufacturer Narrative
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An event regarding altr and pseudotumor involving an unknown head was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned. -clinician review: no medical records were received for review with a clinical consultant.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that the patient was revised due to altr.The exact cause of the event could not be determined because insufficient information was provided. additional information including device details, operative reports, progress notes, and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : not returned.
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