BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC HIGHCROSS PE LINER

    MDR report key: 3435462 · Received October 18, 2013

    Report

    Report Number
    3005180920-2013-00125
    Event Type
    Injury
    Date Received
    October 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 HIGHCROSS PE ACETABULAR LINER: REF. (B)(4) / LOT 131709 ((B)(4) LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT. FURTHER INVESTIGATIONS HAVE BEEN PERFORMED ON THE RETRIEVED LINERS ((B)(4) ITEMS): THEY DO NOT PRESENT ANY SIGN OF CONTACT WITH THE ANTIROTATIONAL MECHANISM OF THE CUP AND THIS MEANS THAT THEY HAVE NOT BEEN CORRECTLY INSERTED INTO THE CUP, WITHOUT REACHING THE RIGHT FINAL POSITION PRIOR TO IMPACT. THE THREE LINERS HAVE BEEN CORRECTLY IMPACTED INTO A NEW SHELL 56, USED TO PERFORM THIS TEST. A NEW LINER OF THE SAME LOT THAT WAS AVAILABLE IN OUR WAREHOUSE HAVE BEEN MEASURED AND ALL THE DIMENSIONS RESULTED TO BE WITHIN THE SPECIFICATIONS, AS EXPECTED. VERSAFITCUT CC TRIO NO HOLE CUP - DOCUMENT REVIEW: REF. (B)(4) / LOT 124402 ((B)(4) SHELLS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE (B)(4) CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT. A NEW SHELL OF THE SAME LOT THAT WAS AVAILABLE IN OUR WAREHOUSE HAVE BEEN MEASURED AND ALL THE DIMENSIONS RESULTED TO BE WITHIN THE SPECIFICATIONS, AS EXPECTED. 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

    REFERENCE # IMP (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535136 VERSAFITCUP CC HIGHCROSS PE LINER ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1