Reported event: an event regarding abnormal ion level involving a trident liner was reported.The event was not confirmed.Method & results: -product evaluation and results: inspection of the returned device noted that no excessive wear was identified on the device.-clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports the revision of a total hip replacement due to elevated titanium ion levels and a worn titanium sleeve.I cannot confirm that this event took place since i was not able to see any medical documentation, office notes, operation report, or photos of the explanted devices.Regarding the possible root cause of this event, i cannot determine it with certainty.In my experience this an extremely rare occurrence but possible causes may be due to surgical technique factors, implant factors, and patient factors.-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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as medical documentation, office notes, operation report 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.
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