BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC ANOTOMIC POR. FEM.

    MDR report key: 349681 · Received August 29, 2001

    Report

    Report Number
    1825034-2001-00072
    Event Type
    Injury
    Date Received
    August 29, 2001
    Date of Event
    July 17, 2000
    Report Date
    August 28, 2001
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BILATERAL TOTAL KNEE ARTHROPLASTY PERFORMED IN 1995. REVISION PERFORMED IN 2000, DUE TO LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39263 AGC ANOTOMIC POR. FEM. PROSTHESIS, KNEE, COMP. JWH BIOMET, INC. NA 094033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R