STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 6021-4535 |
Device Problems
Degraded (1153); Detachment of Device or Device Component (2907)
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Patient Problem
Ambulation Difficulties (2544)
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Event Date 04/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding disassociation and wear involving accolade stem was reported.The event was not confirmed.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of an nc and capa.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: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including lot details, operative reports, progress notes, x-rays 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 : device not returned.
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Event Description
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It was reported by patient's attorney as a result of a legal claim that the patient was implanted with an accolade tmzf hip stem and lfit anatomic v40 femoral head on his right hip on or about (b)(6) 2009.It is alleged that he developed severe pain in the right hip and the inability to walk or bear weight on the right leg, trunnionosis, almost complete disassociation between the femoral head and neck, and a metallosis.He was revised on (b)(6) 2022.
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Search Alerts/Recalls
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