Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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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The published article ¿comparison of existing and new total knee arthroplasty implant systems from the same manufacturer: a prospective, multicenter study¿ by william g.Hamilton, md, ivan j.Brenkel, frcs, steven l.Barnett, md, paul w.Allen, frcs, kimberly a.Dwyer, phd, ccra, james p.Lesko, phd, stephen r.Kantor, md, mark g.Clatworthy, mbchb, fracs published on december 2021 in the american academy of orthopaedic surgeons was reviewed for adverse events.The purpose of the article was to compare the outcomes over two years of 752 pfc sigma knee constructs to 1129 attune knee constructs.Cement manufacturer is unknown.The study included cohorts from the united states, united kingdom, australia, and new zealand.The following adverse events were identified.Pfc sigma underwent 11 revisions for the following reason: infection.Instability.Loosening.Pain.Attune underwent 20 revisions for the following reason: bone fracture.Crepitus.Infection.Loosening.Pain.Stiffness.The following adverse events were noted with no information regarding the intervention required.Pfc sigma.Stiffness (75), pain (21), infection (18), effusion (11), crepitus-asymptomatic (15), instability (12), crepitus-symptomatic (15), trauma (5), wound complication (8), bone fracture (4), tendinitis (6), neuralgia (2), and loosening (3).Attune.Stiffness (85), pain (56), infection (27), effusion (30), crepitus-asymptomatic (13), instability (14), crepitus-symptomatic (6), trauma (15), wound complication (7), bone fracture (13), tendinitis (6), neuralgia (8), and loosening (1).Radiographic outcomes included the following: pfc sigma.Implant/cement interface gap immediately post-op: femoral (6) and tibial (9).Attune.Implant/cement interface gap immediately post-op: femoral 928) and tibial (15).Radiolucencies were also identified: pfc sigma.Femoral (3) and tibial (1).Attune.Femoral (3) and tibial (1).
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