Reported event: an event regarding disassociation and dislocation involving a uhr head was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the polyethylene portion of the device has minor deformation/nicks.Damage is consistent with explantation.Dimensional & functional inspection: dimensional and functional inspections could not be performed because the device was returned damaged.Deformation of uhmwpe can occur due to time spent implanted, dislocation, explantation, and a variety of other factors, and this damage may not be visibly apparent.Any results received from a dimensional inspection of a damaged device would not be reflective of the manufactured state of the device.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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.Conclusions: it was reported that the patient was revised due to disassociation of the metal head from the uhr bipolar head.Visual inspection of the returned device indicated that the polyethylene portion of the device has minor deformation/nicks.Damage is consistent with explantation.Dimensional and functional inspections could not be performed on the uhr head because the device was returned damaged.Deformation of uhmwpe can occur due to time spent implanted, dislocation, explantation, and a variety of other factors, and this damage may not be visibly apparent.Any results received from a dimensional inspection of a damaged device would not be reflective of the manufactured state of the device.The exact cause of the event could not be determined from the information provided; however, it was reported that the patient was being manipulated to address joint dislocation when the disassociation occurred, and it is likely the forces from this closed reduction may have contributed to the event.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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