It was reported a slow post-op recovery due to pain.The affected juni femoral components, juni tibial baseplates and juni inserts, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed 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.A clinical analysis noted that the cause of pain during the immediate post- operative period of a bilateral knee is normal and is expected during the post- operative healing and rehab phase.Since no other interventions were required and the issue was reported as resolved, no further clinical/medical assessment is warranted at this time.Review of the ifu and risk management files identified the reported failure as potential adverse events.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.
|