An event regarding disassociation and metallosis involving a metal head was reported.The reported event for the disassociation was confirmed by material analysis of the returned device.Method & results: product evaluation and results: visual inpection of the returned device revealed: damage was observed on the distal rim of the head, consistent with contact against a hard object.The taper of the head is shown with damage being observed.This damage was likely from the interaction between the head taper and the trunnion.A detailed image of the proximal end of the taper is shown, with a step being observed.Debris was also observed at the proximal end of the head taper.A sample of the debris was placed on a scanning electron microscope (sem) stub for further analysis.A dimensional analysis of the device showed that the taper height and tooling clearance are within specifications per the drawing cd-06-2200, version s.See dimensional inspection results.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the reported event for disassociation was confirmed.A material analysis was performed and concluded "damage was observed on the stem trunnion and head taper.This damage was consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion after the loss of their taper lock." however, the root cause could not be determined as insufficient medical records were provided.No further investigation 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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