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Model Number TIBIAL INSERT MB SZ 2 LT 6MM |
Device Problem
Fracture (1260)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/14/2024 |
Event Type
Injury
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Manufacturer Narrative
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D10: concomitants: 5912352 - 350-01-02e - taluskappe 2, li.6410420 - 350-31-03 - tibiaplateau mobil 3, li.6330728 - 350-41-02 - tibia inlay mobil 6 mm, 2, li.Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Event Description
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It was reported that a patient, initial left ankle implanted on (b)(6) 2021, underwent a revision procedure on (b)(6) 2024, approximately 2 years 11 months post the initial procedure.The surgeon had to revise the insert / inlay due to a breakage.No parts or pieces fell into the patient.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted device is available for return.No further information.
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Search Alerts/Recalls
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