(b)(4).Concomitant medical products: 42558000601 62477806 partial femur cemented size 6 left medial, 42518200408 63449770 partial articular surface left medial size d 8 mm thickness, 66017775 85545282 palacos bone cement.Report source: (b)(6).Reported event was confirmed by review of x-rays received.Radiographs were provided and reviewed by a health care professional.Review of the available records identified that there is extensive lucency along the tibial implant reflecting osteolysis.The tibial implant shows loosening and posterior subsidence with abnormal tilt of the articular surface.Medical records were reviewed by a health care profession.Review of the available records identified the following: initial implantation op notes revealed uncomplicated initial left partial knee replacement on.Cement was used for the tibial and femoral components.At the 3-month post-op visit, there were no reported problems.At the 1-year post-op visit, the patient reported moderate pain.At the 2-year post-op visit, little medial/lateral instability was noted along with radiographic findings of a tibial fracture.The patient underwent revision surgery to replace the tibial component due to loosening.Visual examination of the returned product identified there is cement/bone residue on the femoral component.There is no cement/bone residue on the tibial tray.The tibial tray shows signs of implantation (surface damage).The articular surface is still attached to the tibial tray.The articular surface is slightly discolored and has nicks on its surface.Dimensional analysis of the tibial tray determined that the product, where measured, was conforming to print specifications.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
It was reported patient underwent initial knee arthroplasty.Cement was used for the tibial and femoral components.At the 3-month post-op visit, there were no reported problems.At the 1-year post-op visit, the patient reported moderate pain.At the 2-year post-op visit, little medial/lateral instability was noted along with radiographic findings of a tibial fracture.Subsequently; the patient underwent revision approximately 2 years post implantation to replace the tibial component due to loosening.Attempts have been made and additional information on the reported event is unavailable.
|