BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA STEMMED NATURAL TIBIA

    MDR report key: 3093632 · Received May 1, 2013

    Report

    Report Number
    2648920-2013-00106
    Event Type
    Injury
    Date Received
    May 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ZIMMER
    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
    188906 PERSONA STEMMED NATURAL TIBIA JWH ZIMMER 62180915

    Patients

    Seq Age Sex Outcome Treatment
    1 Other