H3, h6: the device, used in treatment, was not returned for evaluation but the images provided were reviewed, and the separation was confirmed.The clinical/medical investigation concluded that, reportedly, reportedly, the root cause of the revision was separation of the wedge/femoral component from the press-fit stem.The provided imaging appears to support the complaint.The surgical technique supports the use of correct alignment, impact force and screws.The set screws, however, were reportedly not used during impaction, and therefore, was most likely the contributing factor to the reported event.The patient impact beyond the reported revision procedure and an expected post-operative rehabilitation phase could not be determined.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as procedural variance, abnormal motion over time, bone degeneration, lack of ingrowth and/or traumatic injury.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 complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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