(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 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 femoral distal augment cemented size 9, 9+ 5mm catalog #: 42556606605 lot #: 64707485, 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 0001822565-2024-00669 0001822565-2024-00670 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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