BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2111876 · Received May 29, 2011

    Report

    Report Number
    2111876
    Event Type
    Malfunction
    Date Received
    May 29, 2011
    Date of Event
    March 22, 2011
    Report Date
    May 29, 2011
    Manufacturer
    BIOPRO, INC.
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REMOVED FEMORAL HEAD, SLEEVE, STEM, ACETABULAR LINER, 4 SCREWS AND WIRE. INTRAOPERATIVE FINDINGS REVEALED A LOOSE FEMORAL COMPONENT AND A FRACTURED POLYETHYLENE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FEMORAL HEAD KWY BIOPRO, INC. * *
    2 * POLY CUP KWA BIOPRO * *
    3 * PROSTHESIS, HIP, BALL KWY BIOPRO * *
    4 * PROSTHESIS, HIP, FEMORAL STEM KWY BIOPRO, INC. 13149 *
    5 * SCREWS, WIRE, POLY PLATE HWC BIOPRO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR