BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL

    MDR report key: 4173716 · Received August 19, 2014

    Report

    Report Number
    3005180920-2014-00108
    Event Type
    Injury
    Date Received
    August 19, 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 TRIO SHELL CEMENTLESS SIZE 56: REF. 01.26.45.0056 / LOT 140081 ((B)(4) CUPS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) CUPS BELONGING TO THIS LIT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. THE ISSUE WAS DISCUSSED WITH THE SURGEON AND EH ACKNOWLEDGED THAT INSTEAD OF REMOVING AND RE-REAMING BEFORE TRYING TO SEAT THE CUP, HE USED MORE FORCE COMBINED WITH A HEAVY MALLET. UNFORTUNATELY THE CUP DID NOT GAIN THE STABILITY HE HAD HOPED FOR AND IT WAS FINALLY REVISED. THE EVENT IS HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    IMP REF #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498850 VERSAFITCUP CC TRIO ACETABULAR SHELL ACETABULAR SHELL 56 LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1