The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that this complaint from chili reports the revision of a hip (head, liner and shell) approximately 4 months post implantation, secondary to ¿pain¿ and loosening.No clinical/medical information has been provided for this investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality 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 risk management file and instructions for use documents revealed this failure mode was previously identified.Pain is a potential complication associated with any surgery.Some potential probable causes of this event could include patient reaction or a post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.
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