(b)(4).D10 - concomitant devices - persona revision cemented femoral component plus left size 9+, catalog #: 42504606611, lot #: 64825710.Persona revision offset splined uncemented stem extension 3mm x 17mm x +135mm, catalog #: 42560313517, lot #: 64769719.Persona revision central femoral cone size small, catalog #: 42545001011, lot #: 64751267.Persona revision femoral posterior augment cemented 9, 9+ 10mm, catalog #: 42556806610, lot #: 64739717.Persona revision femoral distal augment cemented size 9, 9+ 5mm, catalog #: 42556606605, lot #: 64707485.Persona revision femoral distal augment cemented size 9, 9+ 5mm, catalog #: 42556606605, lot #: 64769986.Persona revision constrained condylar knee articular surface left 12mm, catalog #: 42512800712, lot #: 64615631.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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: 0001822565-2024-00664, 0001822565-2024-00665, 0001822565-2024-00666, 0001822565-2024-00667, 0001822565-2024-00668, 0001822565-2024-00669, and 0001822565-2024-00671.H3 other text : investigation incomplete.
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It was reported that the patient was prescribed diclofenac to treat limited range of motion, flexion contracture, pain and stiffness approximately three (3) years following the patient's last left knee arthroplasty.Initial operative notes noted no intraoperative complications upon implantation of devices.
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