It was reported that a patient underwent a total knee arthroplasty.Approximately eight years and two months post implantation, the patient underwent revision surgery due to aseptic loosening of the femoral components with a periprosthetic fracture of the femoral condyle.During the revision procedure, the surgeon noted significantly soft bone, synovitis and metallosis.The tibial stem was difficult to remove which resulted in a tibial fracture and unintended disassociation of the tibial stem and offset adapter.All components were revised.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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(b)(4).Date of birth: patient was born in 1937.Concomitant medical products: vngd ssk psc intlk fmrl 60 rt: catalog#183302, lot#667480; vngd dist fem aug 60x5 ll/rm: catalog#184122, lot#346530; rhk 12x80 cemented stem: catalog#159405, lot#2114452; biomet offset tibial tray 63mm: catalog#141481, lot#640750; offset tib tray 5.0mm adaptor: catalog#141491, lot#551170; agc mod tib locking screw: catalog#153103, lot#089550; rhk 12x80 cemented stm: catalog#159405, lot#2084361; biomet tib block 6mm 63: catalog#141741, lot#639830; biomet tib block 6mm 63: catalog#141741, lot#203910; vngd sskpsc tib brg s 12x63/67: catalog#183822, lot#486500; copal g+c cement 1x40: catalog#66017790, lot#76974354.Report source: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2022-01960; 0001825034-2022-01961; 0001825034-2022-01963; 0001825034-2022-01964; 0001825034-2022-01965.Diligence is in progress to determine if the products will be returned to zimmer biomet for evaluation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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