BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII

    MDR report key: 3010344 · Received March 19, 2013

    Report

    Report Number
    1020279-2013-00170
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF GII TIBIAL BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114369 GII GII JWH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention