(b)(4).D10: medical product: cps nut co-cr-mo alloy: catalog#178512, lot#278090; cps centering sleeve 14mm: catalog#178536, lot#65753484; cps sm sht spdl w pins 600lbf: catalog#178366, lot#201280; cps/oss 5cm tpr adapt w/oss sc: catalog#178711, lot#65832852; oss poly lock pin: catalog#150478, lot#65676151; oss reinforced yoke: catalog#150493, lot#65676301; oss poly tibial bushing: catalog#150476, lot#65758797; oss tibial poly bearing 12mm: catalog#150410, lot#434030; oss segmental stacking adapter: catalog#150483, lot#861550, qty#2; cps transverse pin 6pk 28mm: catalog#178526, lot#197640; oss non-mod tib plate short 67: catalog#150417, lot#65676027; oss 3cm diaphysel segment: catalog#150464, lot#65766550; oss 3cm diaphysel segment: catalog#150464, lot#65832502; oss rs 7 cm mod seg fmrl-rt: catalog#161011, lot#65677296; oss rs poly fem bushings set/2: catalog#161034, lot#507810; oss rs axle: catalog#161035, lot#65850072 multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2024-00053; 0001825034-2024-00055; 0001825034-2024-00056.The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
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It was reported that a patient underwent a right orthopedic salvage prosthesis implantation.Subsequently, seven (7) months post-implantation, the patient underwent revision surgery due to disengagement of the compression nut.The affected components were revised without reported complication.All available information has been reported.
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This follow-up report is being submitted to relay additional information.The following sections have been updated: a1; a2; a3; b4; b5; g3; h2; h10.The following sections have been corrected: b3; d6a,b; d10 the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
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