It was reported that a manipulation under anesthesia was performed due to stiffening in the patient's left knee range of motion.The associated juni cobalt chrome femoral component, juni tibial base plate and juni tibial insert were not returned for evaluation.Therefore a product analysis could not be performed.As the batch numbers provided were invalid, after repeated requests, smith and nephew has been unable to obtain the correct batch numbers.Thus, the device history record review cannot be completed.A review of the complaint history for the listed parts revealed prior complaints for the listed failure mode.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated at this time.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient medical information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.
|