BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC LINER

    MDR report key: 4217999 · Received July 30, 2014

    Report

    Report Number
    3005180920-2014-00098
    Event Type
    Injury
    Date Received
    July 30, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC HIGHCROSS PE LINER: REF. 01.26.2839HCT / LOT 091187 ((B)(4) LINERS 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) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. COCR FEMORAL HEAD SIZE 28 M: REF. 01.25.012 / LOT 091889 ((B)(4) HEADS 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) HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMPORTER REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446003 VERSAFITCUP CC LINER ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1