|
It was reported that revision surgery was performed.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 acetabular cup, synergy stem, and modular head 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 modular head and synergy stem.A similar complaint has been identified for the acetabular cup.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.It is noted no x-rays or medical records are available and the implants will not be returned.To date no medical records have been received.Without supporting medical documentation and the return of the device, a thorough medical assessment cannot be performed.In the event medical/clinical records or the implant are received, the clinical task will be re-opened and a thorough assessment may be rendered 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.
|
