BEUDAMED
    FDA Adverse Event Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL

    MDR report key: 3080755 · Received April 19, 2013

    Report

    Report Number
    3006639916-2013-00041
    Date Received
    April 19, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 18, 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

    AFTER IMPLANTING THE CUP VERSAFITCUP CC TRIO, BEFORE THE END OF THE SURGERY, THE SURGEON VERIFIED THROUGH X-RAY THE STABILITY OF THE CUP AND NOTICED THAT THE CUP WAS LOOSE. THE CUP WAS REMOVED PER OP, AND A REVISION CUP HAS BEEN IMPLANTED. WE HAVE BEEN INFORMED ABOUT THE EVENT ON (B)(4) 2013. REFERENCE MFR REPORT NUMBER: 3005180920-2013-00041.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170139 VERSAFITCUP CC TRIO ACETABULAR SHELL ACETABULAR CEMENTLESS CUP O 60 LZO MEDACTA INTERNATIONAL SA 121429

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention