The associated genesis ii resurfacing patellar component, genesis ii oxinium femoral component, genesis ii tibial baseplate and legion cr high flexion insert were not returned for evaluation.A clinical analysis noted that without the explant, physical therapy records, or radiographs, the information provided is insufficient to determine the root cause of left knee stiffness.However, the healing process of the procedure implanting the smith and nephew device, poor rehab, or inflammatory cannot be ruled out and not due to the smith and nephew device itself.In addition, the reported of the patient¿s fall as well as the patient¿s body habitus cannot be ruled out as possible contributing factors.The patients¿ left knee flexion improved from 0-70 prior to the revision to about 0-110° post revision.The future impact to the patient beyond the revision cannot be determined.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
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