No product was returned; visual and dimensional evaluations could not be performed.The device history records for the device were reviewed and identified no deviations or anomalies.Review of the compatibility matrix identified that all the components are compatible.This device is used for treatment.A complaint history search identified no other complaint for the part/lot combination of the femoral component.The primary surgical notes state that the patient complained of severe pain in the left knee and radiographic imaging found minimal osteoarthritis.After resecting the femur and tibia, provisional components were put in place and led to satisfying flexion/extension and varus/valgus stability as well as alignment.After cleaning and press fitting the femoral, tibial and patellar components, there was good patellar tracking without any subluxation.The revision surgical notes state that the patient experienced pain and it was difficult to identify the source of pain.The patellar component was revised a year or two before the total revision.No infection was identified but there was suspicion of femoral loosening.Intra-operatively, osteotomes were used to undercut the femoral component which was easily disimpacted.The tibial component was also removed.The patient is described to be a healthy and active individual.Per the package insert of the femoral component, loosening or fracture/damage of the prosthetic knee components or surrounding tissues, as well as pain are known adverse effects of the tka procedure.The insert also mentions that complications and/or failure of total knee prostheses are more likely in patients with unrealistic functional expectations, physically active patients, and/or with patients that fail to follow through with the required rehabilitation program.No product issue were identified and a definitive root cause cannot be determined with the information provided.
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