This complaint is from a literature source.The following literature cite has been reviewed: rassir r, puijk r, singh j, sierevelt in, vergroesen da, de jong t, nolte pa.Long-term clinical performance of an uncemented, mobile bearing, anterior stabilized knee system and the impact of previous knee surgery.J arthroplasty.2022 oct;37(10):2041-2048.Doi: 10.1016/j.Arth.2022.04.039.Epub 2022 may 5.Pmid: 35526754.Objective and methods: authors sought to determine long term survival and patient reported outcomes of uncemented, mobile bearing, anterior stabilized (cruciate sacrificing) depuy low contact stress (lcs) total knees, exploring associations between prior knee surgeries and outcomes.1,289 procedures were retrospectively reviewed (from years 2000-2010) and the association between previous surgery (no surgery versus meniscectomy versus arthroscopy versus corrective osteotomies) and implant survival was assessed.Primary patella resurfacing was not routinely performed¿only 7 patellas were reportedly resurfaced at primary, utilizing metal-backed ingrowth patella implants.Results: the lcs uncemented mobile bearing knee implant demonstrated excellent five-, ten-, and fifteen-year implant survival results, and excellent patient satisfaction.Previous surgical procedures did not compromise lcs results.42 patients were revised, of which 5 were re-revised.The study provided reasons and interventions for revision¿but did not break these down by specific patient or case.Therefore, some revisions may have multiple reasons and/or interventions described.Reasons for revision surgery aseptic tibial baseplate loosening: 22.Aseptic femur and tibial baseplate loosening: 1.Anterior knee pain: 9.Instability: 7.Re-revision for instability: 3.Persisting knee pain (no loosening): 3.Patella baja: 3.Re-revision for patella baja: 1.Patellar maltracking: 2.Malalignment: 2.Insert spin-out: 2.Suspicion of periprosthetic joint infection: 2.Loose body: 1.Insert fracture: 1.Re-revision for arthrofibrosis: 2.Re-revision for polyethylene wear: 1.Re-revision for symptomatic osteophytes: 1.Interventions during revision procedures: tibial tray revision with stemmed component: 19.Secondary patellar resurfacing: 11.Isolated insert exchange: 9.Re-revision of isolated insert exchange: 6.Tibial tray revision with primary cemented component: 5.Soft tissue release: 3.Re-revision of soft tissue release: 1.Tibial tuberosity osteotomy: 2.Re-revision of tibial tuberosity osteotomy: 1.Dair (with exchange of insert): 1.Femoral revision with stemmed component: 1.Removal of all component and arthrodesis: 1.Revision of all components with stemmed components: 1.Revision of all components with stemmed tibial tray, posterior stabilized insert, and primary stemless: femur: 1.Removal of loose body/osteophytes: 1.Re-revision of removal of loose body/osteophytes: 1.Resection lateral patella: 1.Two-staged revision of all components (with cement spacer and reimplantation of stemmed components): 1.Additional adverse events/interventions: primary intraoperative tibial shaft bone fracture: 4.Primary intraoperative patella bone fracture: 1.Primary patella tendon injury: 1.Re-operation to address prosthetic joint infection: 14.Re-operation to address periprosthetic bone fractures: 13.Manipulation under anesthesia, to treat reduced range of motion: 35.Radiolucent lines (no required treatments/interventions reported): 296.
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.(b)(4).No device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.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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