BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA TM TWO-PEGGED POROUS NATURAL TIBIA

    MDR report key: 4212930 · Received October 24, 2014

    Report

    Report Number
    1822565-2014-01443
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678886 PERSONA TM TWO-PEGGED POROUS NATURAL TIBIA OIY ZIMMER, INC. 62186975

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention