It was reported that 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 has not become available.Without definitive 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 number for a cup and head in search of complaints involving elevated tests results throughout the lifetime of the product.As no device batch numbers were provided for investigation, a manufacturing record review, ifu review and risk management review could not be performed.If more information is received, this investigation will be reopened.No medical records have been received on this complaint.It was reported that a revision was performed due to elevated test results.However the device will not be returned for analysis.Without supporting medical records/documentation, the reported event cannot be assessed and a thorough medical assessment cannot be performed.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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