BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOWMEDICA

    MDR report key: 210663 · Received February 18, 1999

    Report

    Report Number
    210663
    Event Type
    Malfunction
    Date Received
    February 18, 1999
    Date of Event
    January 18, 1999
    Report Date
    January 20, 1999
    Manufacturer
    HOWMEDICA OF MICHIGAN
    Product Code
    HSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RIGHT TOTAL KNEE ARTHROPLASTY 06/24/1996--EXPLANTED--"IMPLANT LOOSE". EXPLANTED AND REPLACED 01/18/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOWMEDICA Implant TOTAL KNEE ELEMENTS HSA HOWMEDICA OF MICHIGAN * 9532302,9312797,9609508,(MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other