BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL 58

    MDR report key: 3290225 · Received August 5, 2013

    Report

    Report Number
    3005180920-2013-00094
    Event Type
    Injury
    Date Received
    August 5, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC TRIO ACETABULAR SHELL 58 - REF. 01.26.45.0058 / LOT 123595 ((B)(4) SHELLS PRODUCED). ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. (B)(4)CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE X-RAYS WERE EVALUATED BY AN EXPERT SURGEON CONTACTED BY MEDACTA AND HE NOTICED THAT THE PROBLEM WAS THE FIXATION OF THE CUP DUE TO TWO DIFFERENT THINGS: A TOO BIG SIZE USED WAS USED; A TOO DEEP REAMING WAS PERFORMED INTO THE PELVIS, WITH ALSO REAMING ON THE LATERAL PART OF THE PUBIC BONE. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366573 VERSAFITCUP CC TRIO ACETABULAR SHELL 58 ACETABULAR SHELL CEMENTLESS LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1