Investigation results: it was reported that during a tha surgery, after implanting the 48 mm r3 outer cup, the liner couldn't be implanted.Procedure was concluded with backup devices from smith and nephew, a 50 mm cup and a 50 mm liner.No additional bone cuts or any injury and a delay of less than 30 minutes were reported.The affected r3 acetabular shell, intended for use in treatment, was returned and evaluated.A visual inspection of the device shows signs of damage, probably from attempted use.Our quality team completed dimensional analysis on the returned product and indicated that a minor deviation was noted for locking groove and it was considered acceptable within tolerance per associated drawing print.No other deviations were noted during inspection.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation.Therefore no further clinical assessment is warranted.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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