An event regarding disassociation and wear at taper resulting in blackened tissue involving an unknown accolade tmzf stem was reported.The disassociation event was confirmed based on medical review.Method & results -product 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: "provided x-ray confirms disassociation.Need operative reports, office/clinical reports, examination of the explanted components, etc." -device history review: could not be performed as lot code information was not provided.¿ -complaint history review: could not be performed as lot code information was not provided.¿ conclusion:¿ while the disassociation event was confirmed based on the x-ray provided, the exact cause of the event could not be determined because insufficient information was provided.¿the reported wear and blackened tissue were not confirmed, and hence root cause could not be determined based on the provided information.Additional information including device details, operative reports, office/clinical reports, pathology reports and examination of the explanted components are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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