BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SL PLUS

    MDR report key: 2855136 · Received December 3, 2012

    Report

    Report Number
    9613369-2012-00128
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    June 7, 2010
    Report Date
    November 27, 2012
    Manufacturer
    SMITH & NEPHEW-SWITZERLAND
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 KWY SMITH & NEPHEW-SWITZERLAND C0709479

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R