BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA PEGGED POROUS TIBIAL COMPONENT

    MDR report key: 4252932 · Received November 12, 2014

    Report

    Report Number
    1822565-2014-01575
    Event Type
    Injury
    Date Received
    November 12, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON HAS OBSERVED RADIOLUCENCY ON ONE YEAR POST-OP X-RAYS FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729805 PERSONA PEGGED POROUS TIBIAL COMPONENT OIY ZIMMER, INC. 62434331

    Patients

    Seq Age Sex Outcome Treatment
    1 Other