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A custom made device was requested to replace the modular head in a revision surgery.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 was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified and this failure 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 a result of the reported event.The available medical documents were reviewed.It was reported that the revision surgery was performed due to increased chromium levels.However, it was communicated via email that there is no consent to provide medical information.Without any supporting medical evidence, the reported event cannot be assessed and a thorough medical assessment cannot be performed.Upon receipt of medical/clinical records, the clinical task will be re-opened and assessed at that time.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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