BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII STANDARD TIBIA B

    MDR report key: 2970149 · Received February 20, 2013

    Report

    Report Number
    8010764-2013-00012
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 19, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73795 GII STANDARD TIBIA B GNS II CMT TIB SIZE 6 {} LEFT JWH SMITH & NEPHEW, INC. 09HT34947

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention