Reported event: an event regarding disassociation and wear involving a metal head was reported.The event was confirmed via evaluation of the provided pictures.Method & results: product evaluation and results: the reported device was not returned; however photographs were provided for review.The photographs show a recently explanted unknown stem; we noticed a visible damage on the stem trunnion, this indicates loss of taper lock.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: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to disassociation and wear.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays 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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