BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITH NEPHEW RICHARD

    MDR report key: 581671 · Received March 9, 2005

    Report

    Report Number
    MW1034900
    Event Type
    Malfunction
    Date Received
    March 9, 2005
    Date of Event
    February 8, 2004
    Report Date
    February 14, 2005
    Manufacturer
    SMITH NEPHEW RICHARD
    Product Code
    LZV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CEMENT REMOVAL INSTRUMENT WAS SCREWED INTO DISTAL END OF CEMENT OF HIP. INSTRUMENT BROKE OFF APPROX 1 TO 1 1/2 INCHES FROM THE END. ANOTHER INCISION HAD TO BE MADE AND WINDOW THE FEMUR TO REMOVE THE PIECE OF BROKEN INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH NEPHEW RICHARD CEMENT REMOVAL INSTRUMENT 7MM - TAP LZV SMITH NEPHEW RICHARD * 03KM04934

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other