BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEXGEN COMPLETE KNEE SYSTEM

    MDR report key: 1023748 · Received March 26, 2008

    Report

    Report Number
    3005751028-2008-00005
    Event Type
    Other
    Date Received
    March 26, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ZIMMER TMT
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED APPROXIMATELY 6 WEEKS AFTER THE LABELED EXPIRATION DATE. THE IMPLANTS REMAINS IMPLANTED IN THE PT AND NO ADVERSE REACTION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SYSTEM TM MONOBLOCK TIBIAL COMPONENT HSH ZIMMER TMT 713551-1

    Patients

    Seq Age Sex Outcome Treatment
    1