Reported event: an event regarding wear involving an accolade stem that was mated with an lfit v40 cocr head was reported.The event was confirmed via evaluation of the provided photograph of the stem and clinician review of the provided medical records.Method & results: product evaluation and results: the reported device was not returned however a photograph of the stem was provided for review.Visual inspection of the provided photograph indicated that the stem is severely worn consistent with loss of taper lock.Clinician review: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical records, pre or postoperative care or postoperative radiographs were provided for review.The pi report asserts a revision surgery but records were not provided.The x-rays do show eccentricity of the head on the trunnion presumably from trunnionosis and wear.Event confirmation: failure of the head-trunnion interface can be confirmed.Revision surgery cannot be confirmed.Increased metal levels cannot be confirmed.Root cause: while the likely failure mechanism would be corrosion at the taper, the root cause of the trunnion failure cannot be ascertained without additional medical records and examination of the implant lot numbers." 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 trunnionosis.The reported accolade stem was mated with an lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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