BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS

    MDR report key: 2925035 · Received January 22, 2013

    Report

    Report Number
    9613369-2013-00004
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    November 23, 2011
    Report Date
    December 24, 2012
    Manufacturer
    SMITH&NEPHEW -SWITZERLAND
    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 A REVISION SURGERY OCCURRED DUE TO IMPLANT LOOSENING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31138 PLUS SL-MIA FEMORAL STEM KWY SMITH&NEPHEW -SWITZERLAND

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R BICON-PLUS CUP NON-CEMENTED, SIZE 5| BICON-PLUS X-LINKED PE-INSERT| BIOLOX CERAMIC BALL HEAD, SIZE 32L