BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL

    MDR report key: 3080671 · Received April 19, 2013

    Report

    Report Number
    3005180920-2013-00041
    Event Type
    Injury
    Date Received
    April 19, 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 O 60 - REF. (B)(4)/ LOT 121429 (B)(4). ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. (B)(4). FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    REFERENCE IMPORTER REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169969 VERSAFITCUP CC TRIO ACETABULAR SHELL ACETABULAR CEMENTLESS CUP O 60 LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1