BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP DM ACETABULAR SHELL

    MDR report key: 1981123 · Received February 1, 2011

    Report

    Report Number
    3005180920-2011-00003
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 28, 2010
    Report Date
    February 1, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE O-RING IN THE IMPACTING RING INSTRUMENT PINCHED TOGETHER AND WOULD NOT RELEASE THE CUP INSIDE THE ACETABULUM. THE SURGEON HAD TO PULL IT OUT COMPLETELY AND PUT IN A NEW CUP USING THE SAME IMPACTING RING. THIS ADDED 15 MINUTES TO THE SURGERY. THE IMPLANT INVOLVED IS A VERSAFITCUP DM ACETABULAR SHELL 0 56, ((B)(4), LOT 103046). WHILE THE INSTRUMENT ASSOCIATED IS AN IMPACTING RING 0 56, (B)(4), LOT 097379. DOCUMENT REVIEW OF THE TWO LOTS MANUFACTURED BY MEDACTA WAS CARRIED OUT: ALL THE VALUES WERE FOUND TO BE IN ACCORDANCE WITH SPECIFICATIONS IN FORCE AT THE TIME OF PRODUCTION AND NO ANOMALIES WERE FOUND CONCERNING THE QUOTES RELATIVE TO THE COUPLING BETWEEN THE IMPLANT AND THE INSTRUMENT. NINE SHELLS OF THE LOT 103046 (25 PIECES PRODUCED) WERE ALREADY IMPLANTED, ALL IN THE USA. NO SIMILAR EVENTS WERE REPORTED, INVOLVING THESE TWO LOTS. THE EVENT IS THOUGHT TO BE ASSOCIATED TO AN IMPROPER POSITIONING OF THE IMPACTING RING INTO THE SHELL.

    Description of Event or Problem · 1

    PART FAILED DURING SURGERY. THERE WAS NO HARM FOR THE PT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP DM ACETABULAR SHELL ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 103046

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK IMPACTING RING - INSTRUMENT: REF. 01.26.10.0138,| LOT 097379