BIOMET UK LTD. DELTA CER FEM HD 32/+3MM T1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Catalog Number 650-1161 |
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 Date 10/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 - associated products: g7 vit e neutral lnr 32mm d; item# 30103204; lot# 65454328, g7 pps ltd acet shell 50d; item# 010000662; lot# 7271006, tprlc 133 t1 pps so 11x142mm; item# 51-103110; lot# 7194648.G2 - foreign: netherlands.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported after a right tha, the patient experienced a thrombosis approximately six weeks postop.Patient was treated with anticoagulant therapy and the event was resolved seven months later.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Deep vein thrombosis (blood clot), 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-operatively to prevent dvt formation.Even with the administration of preventive medication, dvts can still develop.As the complaint indicated, a post-operative complication occurred, and medical intervention was required for treatment.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.H3 other text : not device related.
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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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