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
Detachment of Device or Device Component (2907)
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Patient Problem
Ambulation Difficulties (2544)
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Event Date 10/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding disassociation involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other similar event for the lot referenced.Conclusions: it was reported that the patient was revised due to stem-head disassociation.The subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of ncand 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 analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.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 anatomic v40 femoral head and an accolade tmzf hip stem.He underwent revision surgery on (b)(6) 2022, due to alleged head disassociation.
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