BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS RT MOD SOLU STEM STRGHT 14/160

    MDR report key: 1081615 · Received July 25, 2008

    Report

    Report Number
    9612771-2008-00036
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 25, 2008
    Manufacturer
    SMITH & NEPHEW ORTHOPEDICS AG
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED 40 MINUTES DUE TO THE STEM NOT ENGAGING IN THE FEMORAL COMPONENT. IT ALSO RESULTED IN AN UN-PLANNED BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS RT MOD SOLU STEM STRGHT 14/160 406020202014 KWY SMITH & NEPHEW ORTHOPEDICS AG NA D0705665

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R PRODUCT # : LOT # : 0611134694| PRODUCT # : LOT # : D0706180| PRODUCT # : LOT # : F0709474