BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 473539 · Received July 18, 2003

    Report

    Report Number
    MW1029037
    Event Type
    Injury
    Date Received
    July 18, 2003
    Date of Event
    July 7, 2003
    Report Date
    July 18, 2003
    Manufacturer
    MUSCULOSKELETAL TUMOR FOUNDATION, EDISON CORPORATE CENTER
    Product Code
    LMO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT IS STATUS POST TOTAL KNEE REPLACEMENT WHO PRESENTED WITH AN UNSTABLE KNEE AND LOOSE PROSTHETIC. PT UNDERWENT A FEMORAL ALLOGRAFT IN 2003. THE ORTHOPAEDIC SURGEON SWABBED THE ALLOGRAFT PRIOR TO IMPLANTATION. LATER THE CULTURE GREW OUT COAGULASE NEGATIVE STAPHYLOCOCCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FEMORAL HEAD ALLOGRAFT LMO MUSCULOSKELETAL TUMOR FOUNDATION, EDISON CORPORATE CENTER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention