Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis (2100)
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Event Date 12/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical products: nexgen lps femoral component catalog # 00599601852 lot # 64480322; lps allpoly tib sz 7 blu 10 catalog # 00599600710 lot # 63843447; unknown tibial articulating surface catalog # unknown lot # unknown.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2020-03856, 0001822565-2020-03860, 0001822565-2020-03862.Remains implanted.
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Event Description
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It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was diagnosed with a deep vein thrombosis.No revision procedure or further intervention has been reported to date.Attempt for further information has been made, but no further information has been provided.
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Event Description
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Patient was placed on dvt prophy of compression devices through hospital stay.Further, patient was given 325mg ec asa which was started on post op day 1 for home dvt prophy.
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Manufacturer Narrative
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This follow-up report is being filled to relay additional information, which was unknown.D11 medical records: depuy smart set hv bone cement catalog # unknown lot # unknown.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.It was reported the patient developed a dvt approximately 6 days post op.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Deep vein thrombosis, 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-operative for a period of time to prevent the development of dvt/blood clot.Even with the administration of preventive medication, dvt/blood clots can still develop.It was noted that the patient was placed on dvt prevention post op, with use of compression devices during hospital stay, as well as it was ordered for patient to start taking 325mg asa on pod1 for home dvt prevention.It is recorded that patient had elevated bmi of 30.75 increase the risk for post operative dvt development.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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