BEUDAMED
    FDA Adverse Event Summary report: N

    QUADRA H FEMORAL STEM

    MDR report key: 3162626 · Received June 5, 2013

    Report

    Report Number
    3006639916-2013-00055
    Date Received
    June 5, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION. ALL THE IMPLANTS WERE REMOVED AND THE PT WAS TREATED WITH ANTIBIOTIC-IMPREGNATED CEMENT SPACER. IT WAS REPORTED THAT THE PT UNDERWENT A REVISION SURGERY 2 YEARS POST PRIMARY, THE FEMORAL STEM WAS REPLACED DUE TO LOOSENING. THE INFECTION OCCURRED 5 YEARS AND 6 MONTHS POST-PRIMARY AND 3 YEARS AND 5 MONTHS POST -REVISION OF THE STEM. REF MFR REPORT 3005180920-2013-00055.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248980 QUADRA H FEMORAL STEM FEMORAL STEM SIZE 5 LAT CEMENTLESS LZO MEDACTA INTERNATIONAL SA 061382

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CERAMIC BALL HEAD NOT MARKETED IN THE USA.| SHELL,| CERAMIC LINER AND,