H3, h6: the associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device confirmed the stated failure mode.The post of the device is warped, rendering the device inoperative.The face and base of the device is severely scratched.The device shows signs of extensive use.The clinical/medical evaluation concluded that per case details, a revision was performed after a tka.The date of the primary surgery was unspecified.Reportedly, ¿the poly explanted appears to have a warped post and the patient¿s current health status is unknown.It has been reported that no additional requested information was provided.Without clinically relevant information for evaluation, the root cause of the reported warped post and revision cannot be definitively concluded.Further patient impact beyond the reported event could not be assessed.No further medical assessment could be rendered at this time.A review of complaint history did not reveal similar events for the listed device.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 do not have 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 document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Potential probable causes could be but are not limited to wear and/or deformation from surgical procedure, patient anatomy, or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.
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