STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE II HIP STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_SHC |
Device Problems
Degraded (1153); Detachment of Device or Device Component (2907)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 08/01/2023 |
Event Type
Injury
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Event Description
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It was reported through the filing of a lawsuit that allegedly on or about on (b)(6) 2015, the patient was implanted with an lfit v40 femoral head and accolade ii hip stem.It is further alleged that in 2022, as she was lying in bed, she felt her hip snap.She underwent revision surgery and allegedly it was found that the ball and stem had separated.The surgeon further found electro-chemical corrosion which was causing her metallosis.
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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.H3 other text : device not returned to the manufacturer.
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Search Alerts/Recalls
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