BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER UNI FEMORAL COMPONENT

    MDR report key: 2800926 · Received October 18, 2012

    Report

    Report Number
    1822565-2012-02146
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO IMPLANT FRACTURE AND POLYETHYLENE WEAR WITH POTENTIAL MALALIGNMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER UNI FEMORAL COMPONENT HSX ZIMMER, INC. 60634310

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LOT #60169972, ZIMMER UNI TIBIAL COMPONENT,| ZIMMER UNI ARTICULAR SURFACE, CATALOG #00584202509| CATALOG #00584200502, LOT #60718025