The literature article entitled, "total knee arthroplasty in severe valgus deformity using a modified techniques a 10-year follow-up study" written by adam tucker, mb, mrcs, mphil, seamus o'brien, phd, emer doran, bsc, dipn, nicola gallagher, phd, david e.Beverland, md, frcs published by the journal of arthroplasty made available online on 18 september 2018 was reviewed.The article's purpose was to report results from a 10 year follow up of a previously reported study.The previous study was reviewed and reported appropriately under (b)(4).This complaint will capture any newly reported adverse events within this article since the last study's article ((b)(4)).Cement manufacturer not identified.Patella resurfacing was not performed in any patient.Depuy product: uncemented lcs femoral, lcs insert, uncemented/cemented lcs tibial tray.Adverse events reported from previous study (refer to (b)(4)): tray subsidence (treated by revision), infection and/or hematoma (treated by washout only), spinout (treated by closed reduction and long-leg plaster).Adverse events to report from this article's 10 year follow up data: periprosthetic fracture (femoral, treated by open reduction internal fixation or im nail) pus in knee (infection culture was negative, treated by washout only, continues to have pain at 10 year follow up)."knee stiffness" (treated by manipulation under anesthesia).
|
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.
|