BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX ILK ANA RF PS FEMORAL VII

    MDR report key: 317207 · Received February 19, 2001

    Report

    Report Number
    1825034-2001-00016
    Event Type
    Injury
    Date Received
    February 19, 2001
    Date of Event
    September 26, 1999
    Report Date
    February 16, 2001
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    BI-LATERAL TOTAL KNEE ARTHROPLASTY PERFORMED IN 1996. DUE TO PAIN AND INSTABILITY OF LEFT KNEE, REVISION PERFORMED ON THE EVENT DATE. LOOSENING OF THE FEMORAL COMPONENT, OSTEOLYSIS AND WEAR ON THE POLYETHYLENE TIBIAL BEARING WERE FOUND INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6426 MAX ILK ANA RF PS FEMORAL VII PROSTHESIS, KNEE, COMP JWH BIOMET, INC. NA 913510

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R