It was reported that a revision surgery was performed due metallosis.In addition there was severe wear of the femoral head and the polyethylene liner.The affected complaint devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.The potential root causes could included but are not limited to damaged product, implant corrosion or wear.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.
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