BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC FLAT PE LINER

    MDR report key: 4536639 · Received February 13, 2015

    Report

    Report Number
    3005180920-2015-00017
    Event Type
    Injury
    Date Received
    February 13, 2015
    Report Date
    July 25, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02/13/2015: CODE 01.26.2848STT - LOT 072007: 30 LINERS MANUFACTURED AND RELEASED ON 09/28/2007; NO ANOMALIES FOUND. TO DATE, (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR EVENT. ON 02/13/2015 THE R&D MADE A TEST TO QUANTIFY THE WEAR OF THE RETRIEVED LINER, COMPARING ITS WEIGHT WITH THE ONE OF A NEW LINER OF THE SAME SIZE. IT RESULTED TO HAVE A WEAR 100 TIMES HIGHER THAN THE EXPECTED WEAR AT 5 YEARS. THE REASON OF THE EXCESSIVE WEAR IS LIKELY RELATED TO A METAL INCLUSION FOUND ON THE RETRIEVED CERAMIC HEAD, PROBABLY DUE TO A SUBLUXATION CONTACT BETWEEN THE HEAD AND THE METAL BACK. ON 02/13/2015 THE MEDICAL AFFAIRS CHECKED THE X-RAYS RECEIVED AND HE NOTICED THAT THE CUP WAS POSITIONED TO HORIZONTALLY AND THIS COULD HAVE CAUSED AN IMPINGEMENT WITH THE STEM.

    Description of Event or Problem · 1

    IMPORTER REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108926 VERSAFITCUP CC FLAT PE LINER FLAT UHMWPE LINER, LZO, MEH LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown