BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVOLVE MODULAR RADIAL HEAD

    MDR report key: 524936 · Received May 14, 2004

    Report

    Report Number
    524936
    Event Type
    Other
    Date Received
    May 14, 2004
    Date of Event
    March 1, 2004
    Report Date
    March 1, 2004
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWI
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A RADIAL HEAD PROSTHESIS BECAME DISENGAGED AFTER THE PROCEDURE. THE FINAL X-RAY REVEALED THE PROBLEM. THE PT HAD BEEN TAKEN TO THE POST ANESTHESIA CARE UNIT AND WAS THEN TAKEN BACK TO THE OPERATING ROOM FOR REPAIR. REPAIR REQUIRED REMOVAL OF THE IMPLANT WITH BACK TABLE RE-ASSEMBLY AND REIMPLANTATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLVE MODULAR RADIAL HEAD RADIAL HEAD PROSTHESIS KWI WRIGHT MEDICAL TECHNOLOGY, INC. * 10354867
    2 EVOLVE MODULAR RADIAL PROSTHESIS RADIAL STEM KWI WRIGHT MEDICAL TECHNOLOGY, INC. * 07226488

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other