STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 6720-0635 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 01/05/2022 |
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 other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.H3 other text : not available.
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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) 2012, and was implanted with an lfit v40 femoral head and accolade ii stem.He underwent revision surgery on (b)(6) 2022, due to alleged adverse local tissue reaction.
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Search Alerts/Recalls
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