BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 2082251 · Received May 9, 2011

    Report

    Report Number
    1020279-2011-00155
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 25, 2011
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE GENESIS II LDK WAS IMPLANTED BY ANOTHER SURGEON AS A TWO STAGE TREATMENT FOR INFECTION. NO OTHER DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II INSERT JWH SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION 10FM11520

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R PART # 71420326, LOT # 03CM09823