Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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This complaint is from a literature source.The following literature cite has been reviewed: liu c, varady n, antonelli b, thornhill t, chen af.Similar 20-year survivorship for single and bilateral total knee arthroplasty.Knee.2022 mar;35:16-24.Doi: 10.1016/j.Knee.2022.02.001.Epub: 2022 feb 14.Pmid: 35176554.Objective and methods: the purpose of this study was to compare implant survivorship between patients undergoing primary single, simultaneous bilateral, and staged bilateral total knee arthroplasty (tka) with 15-year minimum follow-up.Retrospective study included 826 patients (1089 knees), divided into single (454 knees), simultaneous bilateral (266 knees), or staged bilateral (369 knees) utilizing depuy sigma total knee implants.Reoperation was defined as all surgeries performed on the knee after the index procedure; revision tka was defined as complete implant exchange.Results: overall tka survival rates were very similar in all three groups (97.7% = simultaneous, 97.2% = staged, 96.7% = single).Simultaneous bilateral tkas exhibited similar range of motion, implant survival, and rates of reoperation to staged bilateral and single tka.The following numbers of complications requiring re-operations and revisions were reported: 5: infection: surgical i&d washout.6: infection: i&d washout with liner exchange.2: infection: antibiotic spacer (definitive/complete explantation).3: infection: single stage revision (complete revision tka).9: infection: 2 stage revision (complete revision tka).2: implant bearing wear-tibial tray: tibial tray exchange.2: implant bearing wear- polyethylene liner: liner exchange.7: implant bearing wear- polyethylene liner w/ severe osteolysis: complete revision tka.2: tibial tray implant loosening.1: femur implant loosening.4: severe osteolysis with femur & tibial tray loosening.9: arthrofibrosis-manipulation under anesthesia.3: arthrofibrosis-arthroscopic license of adhesions.1: arthrofibrosis-arthroscopic license of adhesions & liner exchange.4: periprosthetic femur fractures: orif and total knee revision.3: extensor mechanism rupture.1: patella fracture: orif.5: pain.1: pain w/ acl remnant and osteophyte: tissue excision liner exchange.1: pain w/ patella mal-tracking: complete revision tka.1: pain w/ fat necrosis: washout and tissue excision.1: pain -> meniscectomy.1: pathologic lesion.1: avascular necrosis.
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