BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2792378 · Received October 5, 2012

    Report

    Report Number
    2792378
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    July 19, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    NRA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILED LEFT KNEE UNICOMPARTMENTAL ARTHROPLASTY. EXPLANTED HARDWARE: 1 FEMORAL COMPONENT, 1 TIBIAL COMPONENT, AND 1 POLYETHELENE COMPONENT. CONVERSION TO TRICOMPARTMENTAL LEFT TOTAL KNEE ARTHROPLASTY WITH MEDIAL TIBIAL AUGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PROSTHESIS, UNICOMPARTMENTAL KNEE NRA ZIMMER, INC. 60667966T UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR