It was reported that in a clinical study the patient had elevated metal ions.The devices, all of which were used in treatment, remain implanted.As of today, additional information has been requested for this complaint but have not become available.A review of the complaint history for the r3 liner, r3 shell, modular head, modular sleeve and synergy 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 stem and shell.Similar complaints have been identified for the liner, head and 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 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.Smith and nephew has not received patient specific information or the adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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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