It was reported that, after a tha in which a bhr construct had been implanted on the left hip, the implants failed in an unknown way.The patient underwent a unknown revision surgery 10 years ago to treat the adverse event; the patient received a metal-on-metal system instead.
|
It was reported that left hip 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.As no device part and batch numbers were provided for investigation, a complaint history review, 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.The available clinical documents were reviewed.Based on the clinical information provided, of the elevated metal ion levels and the effusions may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The symptoms and details around his reported encephalopathy were not provided.Post removal levels of cobalt and chromium were not provided.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.
|