BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC HIGHCROSS PE LINER

    MDR report key: 3465918 · Received October 31, 2013

    Report

    Report Number
    3005180920-2013-00134
    Event Type
    Injury
    Date Received
    October 31, 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 HIGHCROSS PE ACETABULAR LINER: REF. (B)(4) / LOT 132704 ((B)(4) LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. THE (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT. VERSAFITCUP CC TRIO NO HOLES CUP (K122911): REF. (B)(4) / LOT 130021 ((B)(4) SHELLS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. THE (B)(4) CUPS BELONGING TO THIS LOT HAVE ALREADY SOLD WITHOUT ANY SIMILAR EVENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED, BUT IT IS MORE LIKELY DUE SOMETHING WRONG DONE BY THE SURGEON DURING THE SURGERY.

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558631 VERSAFITCUP CC HIGHCROSS PE LINER ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1