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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 01/06/2023 |
Event Type
Injury
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Event Description
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It was reported that 23 days post implantation, the patient was diagnosed with a dvt in their right leg.The patient was placed on an oral anticoagulant treatment and the complication was resolved 3 months later.There is no additional information available at the time of this report.
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Manufacturer Narrative
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(b)(4).D10: 30103604 item name g7 vit e neutral lnr 36mm d lot # 65627113.574201040 item name avenir cmpl ha std col size 4 lot # 3060082.00625006525 item name bone scr 6.5x25 self tap lot # j7375825.010000662 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 - 03435, 0001822565 - 2023 - 03436.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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Manufacturer Narrative
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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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Event Description
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There is no update to the prior event description provided.
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Search Alerts/Recalls
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