Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Embolism/Embolus (4438)
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Event Date 11/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: persona femur cemented cruciate retaining (cr) item # 42502606202 lot # 64965966.Persona stemmed 5-degree tibia item # 42532006702 lot # 64931459.Persona all poly patella item # 42540200029 lot # 64843592.Report source: (b)(6).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: 3007963827-2022-00008, 3007963827-2022-00009, 0002648920-2022-00005.
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Event Description
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It was reported patient developed pulmonary embolism three days post implantation.Patient was treated medically.Attempts to obtain additional information have been made; however, no more is available at this time.
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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 experienced a pulmonary embolism 3 days postop.She was medically managed while inpatient which prolonged her hospital say by 4 days until the pe resolved.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.If a dvt/ blood clot breaks free, it may travel through the bloodstream and block blood flow to the lungs.This complication is called a pulmonary embolism.Total joint patients are typically placed on medication post-operative for a period of time to help prevent the development of dvt/blood clot formation that can lead to an pe.As the complaint indicated the patient developed a post-operative complication which prolonged hospitalization to medically manage.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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