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
Material Erosion (1214)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 04/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding abnormal ion level & wear involving a 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 product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports 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 the patient underwent left tha on (b)(6) 2013 and was implanted with an lfit anatomic v40 femoral head and an accolade ii hip stem.Allegedly in the last several months she had increasing pain in the left hip, elevated cobalt level suggesting trunnionosis and was revised on (b)(6) 2022.
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