BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMER ADVANTIM UNCONSTRAINED TIBIAL INSERT

    MDR report key: 440399 · Received January 16, 2003

    Report

    Report Number
    1043534-2003-00002
    Event Type
    Injury
    Date Received
    January 16, 2003
    Date of Event
    April 29, 2002
    Report Date
    December 19, 2002
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KRP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, IMPLANT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMER ADVANTIM UNCONSTRAINED TIBIAL INSERT KNEE COMPONENT KRP WRIGHT MEDICAL TECHNOLOGY, INC. NA 035A015419

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention