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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Article entitled ¿a short-term multicenter analysis of radiolucent lines in a single uncemented rotating platform implant for total knee arthroplasty¿ written by jason desmarais, david dalury, thomas l.Bernasek, david a.Fisher, ryan m.Nunley, marie-claire fickenscher, and robert s.Gorab published in arthroplasty today on february 22, 2022 was reviewed.The purpose of this manuscript is to identify the incidence and progression of rlls in a multicenter study group and to determine their effect on knee functional outcome scores and survivorship at 2 years in patients treated with a single cruciate retaining (cr), uncemented, tka design.227 subjects (227 tkas) were involved in the final follow up.All tkas were implanted with cementless porous coated femoral implant with pegs, a cementless tibial baseplate with 4 porous pegs and a central keel, and a cross-linked, rotating platform articular insert (attune total knee; depuy synthes, warsaw, in).Resurfacing of the patella was left up to the discretion of the surgeon.Adverse events: - rlls in 70 (25%) of the 277 patients in the study group.All patients with rlls at 1 year were followed up for a minimum of 2 years with repeat radiographs.There were no new rlls that emerged at the 2-year follow-up, and none were progressive.-two patients contracted periprosthetic joint infections and were successfully treated with a two-stage exchange.-another patient sustained a quadricep tendon rupture at 3 months after tka.The tendon was repaired, and the patient sustained no further complications.-the final adverse event requiring reoperation involved a 61-year-old female with a preoperative valgus deformity.The tibial implant subsided into varus early in the postoperative period.The obliquity of the implants did not allow for accurate evaluation of rlls, but migration and failure of fixation was obvious.Due to pain, radiographic abnormality, and symptomatic varus deformity, successful revision for aseptic loosening was performed 14 months after the index procedure using a tibial sleeve and stem with retention of the femoral component.No other implants were considered loose or at risk of loosening.Even though implant migration was rare, there was 1 other case of early subsidence of the tibial tray.A 63-year-old female patient, also with a preoperative valgus deformity and osteopenia, was noted to have subtle, early subsidence of the tibial implant migration of the tibial implant into slight varus and extension was estimated to be less than 3 mm, occurred early in the recovery period, and was stable by 3 months.Radiographic images remain unchanged at 3 years of the follow-up, no rlls have been identified, and the patient remains clinically asymptomatic and did not require further surgery.(figure 3).
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