It was reported that hip revision surgery was performed.During the revision, the bhr cup and bhr head were removed.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.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part numbers for a 52mm bhr head and 58mm bhr cup in search of complaints involving infections throughout the lifetime of the product.Similar complaints have been identified for the bhr cup and bhr head.This will continue to be monitored.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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.Smith and nephew has not received the device/adequate materials to fully medically evaluate the complaint.But if additional clinically relevant materials are later received, then 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.
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