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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 Type
Injury
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Manufacturer Narrative
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(b)(4).Source: foreign: country: canada.Literature: review of complications, functional outcome, and long-term survival following conversion of hip fusion to total hip arthroplasty.C.I.Ayekoloye, m.Abu qaoud, m.Radi, s.A.Leon, p.Kuzyk, o.Safir, a.E.Gross.The bone and joint journal.Doi:10.1302/0301-620x.103b7.Bjj-2020-2382.R1.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 event, please see associated reports: 0001822565-2022-02127, 0001822565-2022-02129 and 0001822565-2022-02130.
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Event Description
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It was reported one patient developed postoperative deep vein thrombosis (dvt) in the popliteal vein and underwent successful therapeutic anticoagulation.No additional information.Doi: 10.1302/0301-620x.103b7.Bjj-2020-2382.R1.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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.As the complaint indicated, a post-operative complication developed and medical intervention was required to treat the complication.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.Upon reassessment of the reported event, the stem was determined to be not reportable as the device is not believed to have caused or contributed to the event.The initial report was forwarded in error and should be voided.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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Upon reassessment of the reported event, the stem was determined to be not reportable as the device is not believed to have caused or contributed to the event.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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