It was reported that during tha surgery three sets of the reflection acetabular system were replaced due to the liner not being placed smoothly.The tha was completed with other sn backup devices without patient harm or injury reported.The affected reflection three hole shell, used in treatment, was returned and evaluated.A visual inspection of the returned device shows minor damage on the part, probably from the attempted implantation.A dimensional analysis was performed by quality group to check all critical-to-quality features related to liner mating.No deviations were detected during this analysis.The reported failure mode could not be confirmed via dimensional evaluation of the returned part.Our investigation including a review of the manufacturing records for the listed batch did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of the complaint history revealed no other complaint for the listed batch.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 could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.The requested medical documentation was not provided for inclusion in the medical investigation.No further medical assessment can be rendered at this time.Some potential causes of the reported event could include but are not limited to surgical technique used, size of device or user/procedural variance.No further investigation is warranted for this complaint; however, we 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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