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It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the head / sleeve / stem / 2 screws / hole cover / liner /shell / cable was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head, 2 screws, shell, liner, hole cover, stem and cable.Similar complaints have been identified for the sleeve and this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.It cannot be determined to what extent the patients comorbidities had on his pain and clinical status.It is unknown to what extent the patient¿s reported alcoholism could have affected his bone quality which could have also been a contributing factor to the reported avascular necrosis.Although it was reported the patient had elevated cobalt and chromium serum levels, neither the levels nor the lab reports were provided for review.The reported pain, elevated metal ions as well as intraoperative findings of serosanguineous fluid within the hip capsule as well as purulent material noted behind the shell may be consistent with findings consistent with metal debris.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported metal debris and avascular necrosis cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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