BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SL PLUS

    MDR report key: 2780257 · Received October 10, 2012

    Report

    Report Number
    9613369-2012-00090
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 4, 2012
    Manufacturer
    SMITH&NEPHEW - SWITZERLAND
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SL PLUS FEMORAL STEM COMPONENT JDH SMITH&NEPHEW - SWITZERLAND 0503132110

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R