BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY FIXED UC LINER # 3 / 10 MM

    MDR report key: 3022531 · Received March 21, 2013

    Report

    Report Number
    3005180920-2013-00025
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY UC FIXED LINER SIZE 3 / 10 MM: CODE 02.07.0310FUC / LOT 110872 (30 ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION CYCLES. TWENTY TWO ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, THE INFECTION OCCURRED IS HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO BLOODBORNE INFECTION 16 MONTHS POST OP. THE TIBIAL INSERT WAS SWAPPED FOR THE SAME INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116919 GMK PRIMARY FIXED UC LINER # 3 / 10 MM KNEE TIBIAL INSERT UC FIXED JWH MEDACTA INTERNATIONAL, SA 110872

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention