BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VHS VARIABLE ANGLE PLATE

    MDR report key: 340444 · Received June 21, 2001

    Report

    Report Number
    1825034-2001-00058
    Event Type
    Injury
    Date Received
    June 21, 2001
    Date of Event
    April 9, 2001
    Report Date
    June 21, 2001
    Manufacturer
    BIOMET, INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OPEN REDUCTION INTERNAL FIXATION TO INSTALL HARDWARE IN 2000, DUE TO FEMORAL FRACTURE. APPROX SIX MONTHS POST-OPERATIVE, ANGLE OF PLATE FOUND ALTERED. REVISION PERFORMED ON EVENT DATE TO REMOVE HARDWARE, REPLACING WITH BIPOLAR PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28612 VHS VARIABLE ANGLE PLATE * HRS BIOMET, INC. NA 813290

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR