It was reported that a bhr 42 femoral head that was put in in 2007, was removed due to neck fracture and metallosis.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 manufacturing record review, device labelling / ifu review and risk management review could not be performed.If more information is received, this investigation will be reopened.No medical records or evidence have been received on this complaint.The reported event cannot be assessed and a thorough medical assessment cannot be performed.If notification is received that additional medical documentation has been provided, this complaint will be re-evaluated and a thorough medical assessment rendered.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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