It was reported that the patient underwent a closed reduction due to a dislocation of the cup and the femoral head.The implanted devices, were all used in treatment.Additional information has been requested for this complaint but has not become available".A review of the complaint history for the bhr cup and femoral head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the cup and head 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 and no further actions are required at this time.The available medical documents were reviewed.With the information provided the root cause of the dislocation cannot be confirmed and it cannot be concluded that the event was related to a malfunction of the implant.Although the elevated metal ions and dark stained fluid and tissue may be consistent with meatllosis the root cause of the elevated ions and stained fluid and tissue 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; however 6 weeks post revision it is noted ¿right hip, doing well¿.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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