BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED PRECOAT TIBIAL COMPONANT

    MDR report key: 3946359 · Received July 10, 2014

    Report

    Report Number
    2648920-2014-00168
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    December 17, 2012
    Report Date
    June 12, 2014
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER 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 PATIENT WAS REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405029 NEXGEN STEMMED PRECOAT TIBIAL COMPONANT JWH ZIMMER 60376226

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NEXGEN ALL POLY PATELLA, CAT #00597206529| LOT #60335643