ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 13 MM; PROSTHESIS, KNEE
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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
Embolism (1829)
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Event Date 03/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item#:42502806402, femur trabecular metal cruciate retaining, lot#: 64507673.Item#:42530007902, natural tibia trabecular metal two-peg, lot#: 64141027.Item#:00587806538, nexgenâ® complete knee solution, trabecular metal standard primary patella, lot#: 64386822.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.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: 3005751028 -2020 -00064, 0001822565 -2020 -01912, 0001822565 -2020 -01913.
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Event Description
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It was reported that a patient underwent an initial right unilateral total knee arthroplasty on and subsequently, the patient developed a right lower extremity dvt approximately one week later, requiring an unknown medical intervention.The dvt was resolved approximately one month later.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.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 it can be implied medical intervention was required to treat the complication, therefore our complaint category, medical: procedure related.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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This follow-up report is being submitted to relay additional information.
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