The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a revision surgery was performed due to infection.Reportedly, "the doctor says the devices were not defective".It was communicated that the requested medical documentation/information is not available for inclusion in the medical investigation.Based on the limited information provided, the root cause of the revision was the reported infection, although the source of infection remains unknown.The patient impact beyond the reported infection and subsequent revision could not be determined.No further medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to contamination, patient reaction, post-operative healing issue, traumatic injury, joint tightness, material in use, or loss of sterility.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
|