BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII STANDARD TIBIA B

    MDR report key: 2946353 · Received February 6, 2013

    Report

    Report Number
    1020279-2013-00075
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE LOOSE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50902 GII STANDARD TIBIA B GNS II CMT TIB SIZE 6 RIGHT JWH SMITH & NEPHEW, INC. 08GM11150

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention (B)(4)| (B)(4)| (B)(4)