The device was not returned for evaluation, the reported event of dislocation could not be confirmed but the damage of the liner could be confirmed with the intraoperative photo.The clinical/medical investigation concluded that, per case details, approximately six years post total hip replacement surgery, it was reported the patient experienced a ¿mechanical fall¿ which led to several dislocations and a subsequent revision due to a damage liner.One intraoperative photo of the of the liner was reviewed and appears to show evidence of damage.The patient¿s current health status is reportedly ¿well and recovering.¿ no additional requested supporting documentation was provided.Without the requested clinically relevant supporting documentation or the return of the implants, a thorough medical investigation cannot be rendered not can the root cause of the reported failure be determined.However, we cannot rule out the reported fall as a likely contributing factor.The patient is reportedly, ¿well and recovering.¿ 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 complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for hip systems revealed that dislocation has been identified as warnings and precautions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.The contribution of the device to the reported event could be corroborated since it was damaged and a revision surgery was required.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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