BEUDAMED
    FDA Adverse Event Summary report: N

    GMK SC TIBIAL INSERT FIXED SIZE 4/10MM

    MDR report key: 3162620 · Received June 5, 2013

    Report

    Report Number
    3006639916-2013-00063
    Date Received
    June 5, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SEMI-CONSTRAINED INSERT CAME LOOSE. THE PROBLEM WAS NOTICED DURING A VISIT. A REVISION SURGERY WAS PERFORMED AND THE INSERT WAS REPLACED. REF MFR REPORT 3005180920-2013-00063.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249267 GMK SC TIBIAL INSERT FIXED SIZE 4/10MM KNEE SEMI CONSTRAINED TIBIAL INSERT NJL MEDACTA INTERNATIONAL SA 110067

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention