BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL A/P LIPPED TIBIAL INSERT

    MDR report key: 422185 · Received October 9, 2002

    Report

    Report Number
    2219689-2002-00160
    Event Type
    Malfunction
    Date Received
    October 9, 2002
    Date of Event
    September 16, 2002
    Report Date
    September 16, 2002
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    HSH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERT WOULD NTO LOCK INTO THE BASEPLATE. ANOTHER INSERT WAS OPENED AND INSERTED WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL A/P LIPPED TIBIAL INSERT IMPLANT HSH HOWMEDICA OSTEONICS NA XVUVA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other