STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE #2 STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_SHC |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Ambulation Difficulties (2544)
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Event Date 06/26/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding disassociation involving an unknown accolade stem 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: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to head and stem disassociation.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become 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) 2011, and was implanted with an lfit v40 femoral head and an accolade stem.She underwent revision surgery on (b)(6) 2023, due to alleged head disassociation.
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