BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII STANDARD TIBIA B

    MDR report key: 3954200 · Received July 24, 2014

    Report

    Report Number
    8010764-2014-00034
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433396 GII STANDARD TIBIA B GNS II NON-POR TIB SZ 7 RIGHT JWH SMITH & NEPHEW, INC. 11CT05355

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R (B)(4)| (B)(4)