Product complaint # (b)(4).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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This complaint is from a literature source.The following literature cite has been reviewed: quinn j, jones p, randle r.A reliable surgical approach to revision total knee arthroplasty.Clin orthop surg.2022 jun;14(2):213-219.Doi: (b)(4).Epub 2021 jun 3.Pmid: 35685980; pmcid: pmc9152900.Objective and methods: the purpose of this article is to report on the surgical procedure and 90-day complication rates for 202 pfc revision knees implanted between 2004 and 2015.The authors indicated that an unknown number of augments, sleeves, and stems were implanted along with the femoral component, tibial tray and tibial insert.There is insufficient information to determine if the natural patellas were resurfaced.The manufacturers of the products explanted during the revision as well as the cement utilized with the pfc sigma revision knees are unknown.This complaint will capture the information regarding the known 25 postoperative complications associated with the pfc sigma revision knee.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: tc3 femoral component, femoral augment, femoral adaptor, femoral bolt, femoral metaphyseal sleeve, and universal femoral stem; mbt tibial tray and tibial metaphyseal sleeve; pfc tibial insert; universal tibial stem.Adverse event(s) and provided interventions associated with depuy devices: 6 deep infections requiring revision of unknown products 9 reports stiffness and reduced rom treated with mua 1 hemarthrosis secondary to postoperative warfarin administration: conservative management unspecified 1 pe treated conservatively by pulmonologist 6 reports superficial surgical site infections: 1 treated with iv antibiotics, 5 treated with oral antibiotics.1 wound dehiscence secondary to fall from the hospital bed repaired surgically 1 report post operative pain requiring re-hospitalization.Treatment unspecified.
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