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It was reported that a revision surgery was performed due to a dislocation.The associated tandem unipolar taper sleeve and tandem unipolar head, used in treatment, were not returned for evaluation.Thus, no product analysis could be performed.Our investigation including a review of the manufacturing records for the reported batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the reported parts 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 products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.It was communicated that the surgeon stated, there was a significant deformity in the anterior part of the patient¿s acetabulum, and that was why the femoral head kept dislocating.A review of instructions for use revealed the alleged failure is previously identified in the potential adverse events.Per our risk assessment, possible causes could include but not limited to improper leg length and hip joint stability.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved and no patient records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as needed.Should additional information be received, this complaint will be reopened and reevaluated.
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