BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA STEMMED NATURAL TIBIA COMPONENT

    MDR report key: 3093692 · Received May 1, 2013

    Report

    Report Number
    1822565-2013-00736
    Event Type
    Injury
    Date Received
    May 1, 2013
    Report Date
    April 1, 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 IS REPORTED THAT THE PATIENT'S 4 WEEK POST OPERATIVE X-RAYS SHOWED RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF TIBIAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189869 PERSONA STEMMED NATURAL TIBIA COMPONENT JWH ZIMMER INC 62165639

    Patients

    Seq Age Sex Outcome Treatment
    1 Other