It was reported that a revision surgery was performed due to the cup being in an incorrect position and causing a squeaking with the ceramic hip.The affected r3 acetabular shell, r3 delta ceramic liner, synergy high offset stem and biolox delta head, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Possible causes could include but not limited to size of device or alignment of implants.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.
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