BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VHS VARIABLE ANGLE PLATE

    MDR report key: 354924 · Received October 5, 2001

    Report

    Report Number
    1825034-2001-00091
    Event Type
    Injury
    Date Received
    October 5, 2001
    Date of Event
    August 1, 2001
    Report Date
    October 5, 2001
    Manufacturer
    BIOMET, INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OPEN REDUCTION AND INTERNAL FIXATION OF LEFT HIP PERFORMED IN 2000, FOLLOWING SUBTROCHANTERIC FRACTURE. REVISION PERFORMED IN 2001, DUE TO PAIN IN LEFT HIP AND POSSIBLE NON-UNION. INTRAOPERATIVELY, IT WAS NOTED THAT FOUR VHS 4.5 CORTICAL SCREWS WERE FRACTURED. ALL HARDWARE WAS REMOVED, WITH THE EXCEPTION OF TIP OF FRACTURED SCREWS, WITH APPARENT COMPLETE UNION OF FRACTURE. SUBSEQUENTLY, ONE MONTH LATER, REMAINING SCREW TIPS WERE REMOVED DURING PROCEDURE TO IMPLANT BIPOLAR HEAD/NECK PROSTHESIS FOR REPORTED NON-UNION OF EXISTING FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44962 VHS VARIABLE ANGLE PLATE FIXATION, TRAUMA, COMP. HRS BIOMET, INC. NA 058160

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R