BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 50

    MDR report key: 5685328 · Received May 27, 2016

    Report

    Report Number
    3005180920-2016-00248
    Event Type
    Injury
    Date Received
    May 27, 2016
    Date of Event
    April 28, 2016
    Report Date
    May 27, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 13 MAY 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION WHILE CHECKING X-RAYS AND COMMENTED AS FOLLOWS: REVISION OF THA TWO YEARS AFTER PRIMARY, REPORTEDLY BECAUSE OF INFECTION. THERE IS NO REASON TO SUSPECT THAT THE DEVICE CAN BE HELD RESPONSIBLE FOR THE PROBLEM. ON 13 MAY 2016 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE IMAGES OF THE EXPLANTS AND COMMENTED AS FOLLOWS: WITH THE INFORMATION AVAILABLE TO DATE, NO CONCLUSIONS CAN BE DRAWN. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. ON 17 MAY 2016 MEDACTA INTERNATIONAL REQUESTED A DOCUMENT REVIEW OF THE NON-MEDACTA INTERNATIONAL IMPLANTS INVOLVED IN THIS COMPLAINT (BOTH NOT MARKETED IN THE USA): IN BOTH THE CASES NO ANOMALIES HAVE BEEN DETECTED BY THE TWO MANUFACTURERS. BATCH REVIEWS PERFORMED ON 27 MAY 2016. (B)(4). NOT AVAILABLE.

    Description of Event or Problem · 1

    DUE TO AN INFECTION, ALL THE COMPONENTS HAVE BEEN CHANGED DURING REVISION SURGERY. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339853 VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 50 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 135371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention