BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA NATURAL TIBIA

    MDR report key: 3080269 · Received April 24, 2013

    Report

    Report Number
    1822565-2013-00691
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 4-WEEK POST-OPERATIVE X-RAYS SHOW RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF THE TIBIAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177139 PERSONA NATURAL TIBIA JWH ZIMMER, INC. 62230980

    Patients

    Seq Age Sex Outcome Treatment
    1 Other