(b)(4).D10 - concomitant devices - orthopaedic salvage system elliptical diaphyseal segment 3cm catalog #: 150461 lot #: 230920, orthopaedic salvage system im stem with screw 17mm x 90mm catalog #: 150364 lot #: 099860, orthopaedic salvage system segmental femoral component 7cm right catalog # 150354 lot #: 782310, orthopaedic salvage system modular tibial baseplate 79mm catalog #: 150424 lot #: 689560, series a thin 3-peg patella 37mm x 8.6mm catalog #: 184788 lot #: 277320, orthopaedic salvage system tibial poly bearing 16mm catalog #: 150412 lot #: 622440, orthopaedic salvage system reinforced yoke catalog #: 150493 lot #: 293580, orthopaedic salvage system poly femoral bushings 2pk catalog #: 150477 lot #: 096430, orthopaedic salvage system axle catalog #: 150480 lot #: 942420, orthopaedic salvage system poly tibial bushing catalog #: 150476 lot #: 540910 the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the devices were discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2023-01928, 0001825034-2023-01929.H3 other text : investigation incomplete.
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It was reported that the patient underwent a right knee arthroplasty revision to address post-operative instability and requiring a different length to stabilize the leg once again approximately six (6) months post-operatively.Attempts have been made, however, no additional information is available.
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