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It was reported that a revision surgery was performed due to septic mobilization of the prosthesis.The affected legion oxinium femoral component, genesis ii cemented tibial baseplate and legion articular insert were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the femoral and the insert did not reveal any deviation from the standard manufacturing processes.The lot number for the baseplate cannot be confirmed.Thus, a review of the manufacturing records for this part cannot be performed.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 or adverse event could not be corroborated.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 records provided, our investigation of this report is inconclusive.We will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.Mimb review: assess severity of complaint case to determine if additional action and further inputs are required for inclusion in medical assessment.Determine if a medical assessment would be performed based on a review of the complaint detail and further recommendations from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by j.Templeton, medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information, surgical procedure/post-operative care review, device labeling (including technique guides, ifus, etc.) details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported component loosening, migration and sepsis cannot be determined.
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