BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO CUP 54

    MDR report key: 2878902 · Received December 14, 2012

    Report

    Report Number
    3005180920-2012-00089
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC TRIO CEMENTLESS CUP 58: (B)(4) / LOT 121913 ((B)(4) CUPS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLES. THE (B)(4) CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. MEDACTA REQUESTED THE OPINION OF A CLINICAL EXPERT WHO CHECKED THE X-RAYS WITH THE FOLLOWING COMMENT: THE SURGERY AT ACETABULUM SEEMS TO BE NOT WELL PERFORMED, THE SHELL IS NOT SEATED PROPERLY AND THERE IS VOID SPACE BEHIND IT. FROM THE DATA COLLECTED, THE ROOT CAUSE OF THE EVENT IS UNKNOWN, BUT IT IS HIGHLY UNLIKELY DEVICE RELATED AND PROBABLY DUE TO SURGICAL MISTAKES OR TO PARTICULAR CONDITIONS OF THE BONE.

    Description of Event or Problem · 1

    PT COMPLAINING OF PAIN POST SURGERY. THE CUP WAS FOUND NOT FULLY SEATED. SURGEON REMOVED THE CUP, RE-REAMED AND REPLACED CUP, LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP CC TRIO CUP 54 ACETABULAR CUP CEMENTLESS LZO MEDACTA INTERNATIONAL SA 121913

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention