It was reported patient underwent a revision procedure one year post implantation due to pain, swelling, instability and a popping sensation in the knee.Attempt for further information has been made, but no further information has been provided.
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This follow-up report is being submitted to relay additional information.H6: suggested code: mechanical g4- femur.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates initial surgery notes or x-ray found no complications.The patient had history of fall due to dizziness but not related to knee implants.The patient reported that the knee area feels warm to touch.Additionally, patient was noted with malrotation, pain, swelling and instability.During the revision surgery, significant anterior notch was found noted and femur component was upsized.The implants were revised without complication.Patella was retained.Post op x-ray noted lucency adjacent to the femoral prosthesis not thought to be a fracture.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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