STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II 127 DEG; LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 6721-0435 |
Device Problem
Corroded (1131)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/14/2022 |
Event Type
Injury
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Event Description
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It is reported by counsel that claimant underwent right tha on (b)(6) 2013, and was implanted with a accolade ii hip stem and a lfit anatomic v40 femoral head.He was revised on (b)(6) 2022, allegedly due to trunnion corrosion.
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Manufacturer Narrative
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Reported event: an event regarding corrosion involving an 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: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to stem trunnion corrosion.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.H3 other text : device not returned.
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Search Alerts/Recalls
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