Reported event: an event regarding disassociation 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 consistent with explantation.Dimensional & functional inspection: dimensional inspection 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.Material analysis: material analysis was not performed as the event does not relate to material integrity.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as lot code information was unknown. -complaint history review: could not be performed as lot code information was unknown. conclusions: it was reported that the patient was revised due to disassociation of the metal head from the bipolar (uhr) head.Visual inspection of the returned device indicated that the polyethylene portion of the device has minor deformation/nicks consistent with explantation.Dimensional inspection 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.Material analysis: material analysis was not performed as the event does not relate to material integrity.Further information such as pre- and post-operative x-rays and the primary & 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
|