BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLER/GALANTE POROUS TIBIAL PLATE

    MDR report key: 2792314 · Received October 12, 2012

    Report

    Report Number
    1822565-2012-02092
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    July 21, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLER/GALANTE POROUS TIBIAL PLATE JWH ZIMMER, INC. 65308000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention CATALOG #00578000500, LOT #75026400.| MILLER/GALANTE POROUS TIVANIUM FEMORAL COMPONENT,