It was reported that a revision surgery was performed to change of inlay from size 62 mm to 60 mm, probably due to previous implantation of an inlay with the wrong size.The affected r3 articular liner, used in treatment, was not returned for evaluation.However, a picture of labels was submitted which showed the sizes are readable with little effort.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.No relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.The reported failure has been noted on the instructions for use and on the risk management files.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to user error or labeling issue.It was communicated that the wrong size was implanted and not noticed intraoperatively as the insert initially jammed well and seemed to be firmly fixed.
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