BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SL PLUS

    MDR report key: 2770046 · Received October 3, 2012

    Report

    Report Number
    9613369-2012-00085
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 9, 2012
    Report Date
    September 5, 2012
    Manufacturer
    SMITH&NEPHEW -SWITZERLAND
    Product Code
    JDG
    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 A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R