BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY CEMENTED FIXED FEMORAL COMPOENNT

    MDR report key: 4143548 · Received September 5, 2014

    Report

    Report Number
    3006639916-2014-00116
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS COMPLAINING OF PAIN. THE SURGEON PRIMARILY THOUGHT THE PAIN WAS DUE TO AN INFECTION AND SCHEDULED A REVISION SURGERY TO IRRIGATE AND DEBRIDE THE AFFECTED AREA. DURING THE PROCEDURE THE SURGEON DETERMINED THAT THE FEMORAL AND TIBIAL COMPONENTS WERE LOOSE WHICH WAS THE CAUSE OF THE PTS PAIN. A TOTAL KNEE REVISION WAS COMPLETED TO FIX PROBLEM. MFR REF# 3005180920-2014-00116.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544949 GMK PRIMARY CEMENTED FIXED FEMORAL COMPOENNT CEMENTED FIXED FEMUR STD SIZE 5 LEFT KWY MEDACTA INTERNATIONAL SA 132786

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CODE 02.07.1205L/ LOT 133120| GMK FIXED CEMENTED TIBIAL TRAY SIZE 5 LEFT: