BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL-KNEE II

    MDR report key: 1972391 · Received January 6, 2011

    Report

    Report Number
    1972391
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE PATELLAR RESURFACING INSTRUMENTATION, THE ROUND PATELLA CENTERING CALIPER ALLOWED THE DRILL BIT TO DRILL TOO DEEP AND PERFORATE THE PATELLA ANTERIOR CORTEX. THREE DRILL HOLES PERFORATED THE PATELLA DUE TO INSTRUMENT DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, INSTRUMENT, DRILL GUI JWH ZIMMER, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR