BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 1020526 · Received March 28, 2008

    Report

    Report Number
    1020279-2008-00099
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 24, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II INSERT HSH SMITH & NEPHEW, INC., ORTHOPAEDIC DIV NA 07HM15727

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R PRODUCT# 71421515| PRODUCT# 71420170| PRODUCT # 71420106