BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 7 -

    MDR report key: 2232608 · Received August 25, 2011

    Report

    Report Number
    3005751028-2011-00060
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Product Code
    JWH
    PMA / PMN Number
    K020295
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED TIBIAL PAIN. ON (B)(6) 2011 THE PT'S FEMORAL COMPONENT, TIBIAL COMPONENT AND PATELLA WERE REVISED. PER THE SURGEON'S ASSESSMENT, THE IMPLANT'S WERE NOT RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 7 - NONE JWH ZIMMER TRABECULAR METAL TECHNOLOGY 60738480

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR