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Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Cyst(s) (1800)
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Event Date 01/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint number (b)(4).Udi: (b)(4).Medical products: vngd cr tib brg 10x71/75 mm; p/n: 183440, l/n: 023500, vanguard cr ilok fem-rt 70; p/n: 183012, l/n: j3811641, biomet ilok pri tib tray 75mm; p/n: 141214, l/n: 675450, biomet finned pri stem 40mm; p/n: 141314, l/n: 746780, bmet arcom ap pat w/wire 34mm ire 34mm; p/n: 11-150828, l/n: 238830, competitor bone cement; p/n: unk, l/n: unk.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: 0001825034-2019-04662.Product location is unknown.
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Event Description
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It was reported the patient had a right knee revision procedure three (3) years post-implantation due to tibial loosening and cyst formation.No additional patient consequences were reported.
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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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This follow-up report is being submitted to relay updated and additional information.Updated: a5, b4, b5, g4, g7.Additional: h1, h2, h3, h6, h10.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Tibia was found to be grossly loose medially and tilting in the varus.A large cyst was found under the tibia.Surgery took an extended amount of time due to patient¿s high bmi.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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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Search Alerts/Recalls
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