BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM PRIMARY TIB. BEAR

    MDR report key: 312825 · Received January 8, 2001

    Report

    Report Number
    1825034-2001-00004
    Event Type
    Injury
    Date Received
    January 8, 2001
    Date of Event
    November 29, 2000
    Report Date
    January 4, 2001
    Manufacturer
    BIOMET, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RIGHT TOTAL KNEE ARTHROPLASTY PERFORMED 08/1997. REVISION PERFORMED 11/2000, DUE TO PAIN AND INSTABILITY. WEAR WAS NOTED ON POLYETHYLENE BEARING COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796 MAXIM PRIMARY TIB. BEAR PROSTHESIS. KNEE. COMP. HSH BIOMET, INC. NA 774700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R