BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO CUP 58

    MDR report key: 2878903 · Received December 14, 2012

    Report

    Report Number
    3005180920-2012-00090
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    October 31, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW ON THE LOTS OF IMPLANTS EXPLANTED: VERSAFITCUP CC TRIO CEMENTLESS CUP 58: CODE (B)(4) / LOT 112455 ((B)(4) CUPS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLES. THE (B)(4) CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE SURGEON THAT PERFORMED PRIMARY AND REVISION SURGERIES ADDED THE FOLLOWING COMMENT: "THERE WERE DIFFICULT CONDITIONS FROM THE BEGINNING IN THIS CASE. I FOUND A OVAL ACETABULUM AND FINALLY I HAD TO MAKE A CANCELLOUS BONE GRAFTING TO BEGIN". ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IN THE PROBLEM OCCURRED IS HIGHLY UNLIKELY.

    Description of Event or Problem · 1

    DESPITE THE FIXATION OF THE TRIO WITH ONE SCREW THE CUP MIGRATED TOWARDS THE PELVIS, DUE TO BONE RESORPTION. NO SIGNS OF INFECTION. REVISION SURGERY WITH A CEMENTED SHELL 2 MONTHS POST OP. WE WERE INFORMED ON (B)(4) ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP CC TRIO CUP 58 ACETABULAR CUP CEMENTLESS LZO MEDACTA INTERNATIONAL, SA 112455

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention