ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS); PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Embolism (1829); Cancer (3262)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown femoral component size e catalog #: unknown lot #: unknown, unknown tibial component 13mm catalog #: unknown lot #: unknown, unknown patella 35mm catalog #: unknown lot #: unknown.The complainant 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 patient; please see all reports associated with this event: 0001822565-2019-04977, 0001822565-2019-04978, 0001822565-2019-04979, 0001822565-2019-05075.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 experienced a blood clot from the surgery.Attempt for further information has been made, but no further information has been provided.
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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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Manufacturer Narrative
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Concomitant medical products: persona femur cemented posterior stabilized (ps) standard catalog # 42500606402 lot # 63362725, persona stemmed tibia catalog # 42532007102 lot # 63315961, persona all poly patella catalog # 42540200035 lot # 63326893, 3.5mm hex head screw x38mm catalog # 20800000018 lot # unknown.Multiple mdr reports were filled for this event: 3007963827-2020-00040, 30007963827-2020-00039.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10 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 would be appropriate.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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