It was reported that revision surgery was scheduled to potentially remove and replace acetabular cup and liner due to suspected loosening secondary to lysis.However, upon inspection, there was a cyst found under the well-fixed cup which was reportedly excised and filled with bone graft along with implantation of a new liner and head.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that medical documentation would not be provided due to lack of consent.Based on the information provided, the root cause of the revision was the cystic formation under the cup which was believed to be loosening/lysis; however, the cause of the cyst could not be concluded.The patient impact beyond the reported findings and interventions could not be determined, as no injury was reported.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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