It was reported that hip revision surgery was performed.During the revision, the r3 shell, r3 liner, modular head and sleeve were removed.The stem 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 r3 shell, r3 liner, modular head and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the r3 shell.This will continue to be monitored.Similar complaints have been identified for the r3 liner, modular head and sleeve.However, as the devices are no longer sold, no action is to be taken.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.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed, but if additional clinically relevant materials are later received the case may be re-opened for further evaluation.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.
|