An event regarding disassociation involving a sleeve was reported.The event was confirmed by review of the provided medical records by a clinical consultant.Method & results: device evaluation and results: visual inspection: ma: damage consistent with the explantation process was observed on the outer surface of the taper adapter.X-ray fluorescence spectroscopy showed that the adapter base material was consistent with astm f67 (cp ti).Functional and dimensional inspection: due to the damage noted in the visual inspection and the fact that the device was implanted and subsequently explanted, a dimensional or functional inspection of the device in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis: ma: damage consistent with the explantation process was observed on the outer surface of the taper adapter.X-ray fluorescence spectroscopy showed that the adapter base material was consistent with astm f67 (cp ti).Based on the given information, there was no materials or manufacturing discrepancies on the surfaces examined.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided undated x-ray image confirms 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: 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history and additional serial dated x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
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