BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TIBIAL COMPONENT BIOMET

    MDR report key: 66339 · Received November 3, 1996

    Report

    Report Number
    66339
    Event Type
    Injury
    Date Received
    November 3, 1996
    Date of Event
    October 29, 1996
    Report Date
    November 3, 1996
    Manufacturer
    BIOMET, TL WEISS AND ASSOCIATES
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 10/18 TIBIAL COMPONENTS REPLACED FOR WORN OUT COMPONENT, IMPLANTED 15 YRS AGO. ON 10/24/96 THE KNEE WAS NOTED TO BE SUBLUXING. PT RETURNED TO OR ON 10/25 FOR COMPLETE REVISION OF RIGHT TOTAL KNEE. (CO FOUND COMPONENT IMPLANTED). MD BELIEVED IT MAY OF BEEN COMBINATION OF THE TIBIAL IMPLANT AND PT'S KNEE STRUCTURE WHICH CAUSED THE SUBLUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET TIBIAL COMPONENT BIOMET Implant TOTAL KNEE HSH BIOMET, TL WEISS AND ASSOCIATES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention