(b)(4).D10: 30103604, item name: g7 vit e neutral lnr 36mm d, lot #: 65627113; 00625006525, item name: bone scr 6.5x25 self tap, lot #: j7375825; 00625006525, item name: bone scr 6.5x25 selftap, lot #: j7375821; 010000662, item name: g7 pps ltd acet shell 50d, lot #: r7304614a; 00877503601, item name: bioloxâ delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14, lot #: 3115418.Multiple mdr reports were filed for this event, please see associated reports 0001822565-2023-03434, 0001822565-2023-03436, and 0001822565-2023-03440.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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This follow-up report is being submitted to relay additional information.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Deep vein thrombosis (blood clot), or dvt, occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operatively to prevent dvt formation.Even with the administration of preventive medication, dvts can still develop.As the complaint indicated, a post-operative complication occurred, and medical intervention was required for treatment.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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