BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE FEMUR SIZE 5 RIGHT

    MDR report key: 4143514 · Received August 21, 2014

    Report

    Report Number
    3006639916-2014-00110
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WOUND NOT COMPLETELY CLOSED, GENERATING AN INFECTION: PROPIONIBACTRIUM. DURING THE REVISION ALL THE IMPLANTS HAVE BEEN REMOVED AND THE PT RECEIVED A CEMENT SPACER. MFR REF# 3005180920-2014-00110.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505135 GMK HINGE FEMUR SIZE 5 RIGHT FIXED CEMENTED HINGE FEMORAL COMPOENTN KRO MEDACTA INTERNATIONAL SA 112424

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention