BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN

    MDR report key: 962449 · Received November 29, 2007

    Report

    Report Number
    MW5004624
    Event Type
    Injury
    Date Received
    November 29, 2007
    Date of Event
    October 24, 2007
    Report Date
    November 29, 2007
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    HRZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT C/O NEW ON SET OF KNEE PAIN, DENIED ANY INJURY OR TRAUMA TO THE KNEE. EXAM COMPLETED IN 2007 AND FELT TO BE A HARDWARE FAILURE. SURGERY SCHEDULED AND COMPLETED FIVE DAYS LATER. BRIEF EXAM OF THE HARDWARE AT REMOVAL IDENTIFIED THAT THE TIBIAL HINGE BASE WAS FRACTURED AND NOTED TO HAVE A SLIGHT BOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN TIBIAL HINGE BASE HRZ WRIGHT MEDICAL 055205397
    2 GUARDIAN SPACER HSA WRIGHT MEDICAL 025136880
    3 GUARDIAN FEMUR AXIAL PIN HTY WRIGHT MEDICAL 11358935

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R