BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VKS

    MDR report key: 1875203 · Received October 19, 2010

    Report

    Report Number
    1020279-2010-00291
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 16, 2010
    Report Date
    April 6, 2011
    Manufacturer
    SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS REPORTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VKS TIBIAL INSERT NJL SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE OR75001466 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R