BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET INC

    MDR report key: 86983 · Received April 25, 1997

    Report

    Report Number
    86983
    Event Type
    Injury
    Date Received
    April 25, 1997
    Date of Event
    March 20, 1997
    Report Date
    April 10, 1997
    Manufacturer
    BIOMET, INC.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    19 YR OLD PT ADMITTED FOR REVISION OF LOOSE TIBIAL POLYETHYLENE BEARING MECHANISM OF THE LEFT KNEE & REPAIR OF THE QUADRICEPS MECHANISM. A 12MM ROTATING HINGE KNEE SYSTEM WAS REPLACED. THE AXLE WAS REPLACED AS WERE THE LOCK PIN AND TIBIAL BUSHINGS. IN ADDITION, THE YOKE AND FEMORAL BUSHINGS WERE REPLACED. PT WAS DISCHARGED TO HOME ON 3/23.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET INC Implant FINN TIBIA BEARING & YOKE KRO BIOMET, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention