It was reported that revision surgery was performed 10 years after th revision surgery resulted in the following intra-operative findings and/or diagnoses: metallosis, metal toxicity, adverse tissue reaction, necrotic tissue around the pseudocapsule and trochanteric bursa, bursa itself was full of fluid, and extensive debridement was required to remove any thickened scar tissue and necrotic debris.
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It was reported that right hip revision surgery was performed.During the revision, the hemi head, modular sleeve and stem were removed.The cup remained implanted.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 bhr cup, hemi head, modular sleeve and stem 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 bhr cup, hemi head and stem.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known 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 and no further actions are required at this time.The available medical documents were reviewed.The reported pain and elevated cobalt, and intraoperative findings of scar tissue, necrotic debris and metal wear on the trunnion may be consistent with trunnionosis and metal debris; however, the root cause cannot be determined nor can it be concluded that the clinical reactions are associated with a mal-performance of the implant.The patient impact beyond the revision 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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