BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS UNI

    MDR report key: 1320962 · Received February 20, 2009

    Report

    Report Number
    1020279-2009-00027
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    December 13, 2007
    Report Date
    February 19, 2009
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPAEDIC DIV.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R PRODUCT NUMBER: 727101| PRODUCT NUMBER: 728109