STRYKER ORTHOPAEDICS-MAHWAH SIZE 3 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 6721-0330 |
Device Problem
Corroded (1131)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 11/17/2022 |
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) 2014.And was implanted with an lfit anatomic v40 femoral head and accolade ii stem.She underwent revision surgery on (b)(6) 2022, due to alleged trunnion corrosion right hip with elevated metal ion levels and pseudotumor.
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Manufacturer Narrative
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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.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.H3 other text: device not returned to the manufacturer.
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Search Alerts/Recalls
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