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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.No part/lot numbers were provided; hence documentation review could not be completed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.It was reported the patient had elevated cobalt and chromium levels; however, neither the levels nor the lab reports were provided for review.Although the reported pain, elevated metal ions and intraoperative findings of fluid collection and trunnion corrosion may be consistent with findings associated with trunnionosis or metalosis; the root cause of the reported pain, elevated cobalt and chromium levels, pseudotumor and metallosis cannot be confirmed and it cannot be concluded that the reported 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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