BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO SHELL

    MDR report key: 4346576 · Received December 9, 2014

    Report

    Report Number
    3005180920-2014-00178
    Event Type
    Injury
    Date Received
    December 9, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K103352
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC TRIO ACETABULAR SHELL: REF. (B)(4)/LOT 131267 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) SHELLS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. AMISTEM H CEMENTLESS STEM (K093944): REF. (B)(4)/LOT 130595 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. ALL THE STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT: CERAMIC FEMORAL HEAD NOT MARKETED IN THE USA; (B)(4) HEADS BOUGHT AND (B)(4) ALREADY SOLD, WITHOUT ANY SIMILAR ISSUE. CERAMIC ACETABULAR LINER NOT MARKETED IN THE USA: (B)(4) BOUGHT AND (B)(4) ALREADY SOLD, WITHOUT ANY SIMILAR ISSUE. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792807 VERSAFITCUP CC TRIO SHELL ACETABULAR CEMENTLESS CUP MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1