BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC-S MOD. TIB. BEARING

    MDR report key: 315146 · Received February 5, 2001

    Report

    Report Number
    1825034-2001-00013
    Event Type
    Injury
    Date Received
    February 5, 2001
    Date of Event
    November 29, 2000
    Report Date
    February 1, 2001
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVISION RIGHT TOTAL KNEE ARTHROPLASTY PERFORMED IN 1999. REVISION PERFORMED ON EVENT DATE, TO REPLACE FEMORAL COMPONENT AND TIBIAL BEARING DUE TO POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4312 AGC-S MOD. TIB. BEARING PROSTHESIS, KNEE, COMP JWH BIOMET, INC. NA 321320

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R