The patient was revised to address pain and loosening of an unknown component.Unknown cement was used.On (b)(6) 2019, the patient underwent a primary left knee arthroplasty with implantation of depuy unicondylar sled prothesis to treat osteoarthritis.Depuy cement was utilized during the procedure.The patella was not resurfaced.There were no indicated intra-operative complications.On (b)(6) 2020, the patient underwent a left knee revision to address pain, adhesion, cysts, crepitus, and tibial tray loosening at the cement to implant interface.All components were removed, and the patella was resurfaced.Depuy products were implanted with depuy cement.On (b)(6) 2021, a left knee x-ray revealed osteolysis beneath the tibial plateau.On (b)(6) 2021, a left knee ct revealed possible tibial tray loosening.On (b)(6) 2021, the patient underwent a left knee aspiration to rule out infection due to increasing pain.The physician aspirated 15 ml of blood-tinged clear effusion and sent for microbiology and cell count.Results of aspiration not given within the available medical records.The physician also indicated a request for allergy testing for the bone cement.No results available regarding an allergy to bone cement.Doi: 2019, dor: unknown.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.This device was manufactured on 18-sept-2017.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.Device history lot : 1) quantity manufactured: (b)(4).2) date of manufacture: 18-sep-2017, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: 31-aug-2022, 5) ifu reference: 090200806.
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