BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY

    MDR report key: 576908 · Received February 22, 2005

    Report

    Report Number
    576908
    Event Type
    Injury
    Date Received
    February 22, 2005
    Date of Event
    February 11, 2005
    Report Date
    February 22, 2005
    Manufacturer
    DEPUY
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT. HAS HAD PROGRESSIVE PAIN ESPECIALLY OVER THE LEFT BUTTOCK AND TROCHANTERIC AREA. X-RAY SHOWS SIGNIGICANT BONE OVE GROWTH OF A KUNTCHER ROD WHICH IS BROKEN THROUGH THE EYE OF THE ROD WITH APPROX. 3-4 CM OVERGROWN AROUND THE TIP IF THE BROKEN ROD. THEIR FEMUR APPEAR WERE HEALED. PT HAS A SIMILAR ROD IN RIGHT FEMUR WHICH MAY SHOW SOME LINE OF FX PROXIMALLY BUT APPARENTLY NOT COMPLETELY BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY KUNTSCHER HSB DEPUY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization