The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, in addition to the violation of the posterior hip precautions/traumatic event at approximately 6 weeks of the 1st revision, the previously identified neutral/vertical version along with off-label use/mixed components could have also been a contributing factor to the reported recurrent instability ((b)(6), (b)(6)).The patient impact beyond the reported symptoms and revisions cannot be determined.No further medical assessment can be rendered at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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.Some potential probable causes for this event could include improper fit/ sizing or a traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
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