BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED NONAUGMENTABLE TIBIA

    MDR report key: 3242922 · Received July 19, 2013

    Report

    Report Number
    2648920-2013-00168
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 21, 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 WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339004 NEXGEN STEMMED NONAUGMENTABLE TIBIA JWH ZIMMER 60832430

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention SURGICAL PRODUCTS| MEDICAL & DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC,| CATALOG #00111314001, LOT #66234138,| PALACOS R+G BONE CEMENT,| THIS BONE CEMENT IS MANUFACTURED AT HERAEUS,