STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 6021-0435 |
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 an accolade stem that was mated with an lfit v40 cocr 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 have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to stem-head disassociation.The reported accolade stem was mated with an lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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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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Search Alerts/Recalls
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