BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO CUP O 50 MM

    MDR report key: 3724327 · Received December 18, 2013

    Report

    Report Number
    3005180920-2013-00171
    Event Type
    Injury
    Date Received
    December 18, 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 CUP O 50 - REF. 01.26.45.0050 / LOT 131269 (100 CUPS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. NINETY TWO CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO OTHER INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, WE DO NOT HAVE EVIDENCES THAT THE EVENT IS DEVICE RELATED BUT SEEMS LIKELY DUE TO A SURGICAL MISTAKE DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 1

    REF IMPORTER REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662686 VERSAFITCUP CC TRIO CUP O 50 MM ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1