Reported event: an event regarding disassociation involving an accolade stem that was mated with a lfit v40 cocr head was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-device history review: indicated all 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.Conclusion: the event itself cannot be confirmed as insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are required 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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