BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP CC CUP IMPACTOR

    MDR report key: 7121392 · Received December 15, 2017

    Report

    Report Number
    3005180920-2017-00742
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 15, 2017
    Report Date
    March 28, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON 05 MARCH 2018 DURING THE INSPECTION IT IS EVALUATED THAT THE WELDING BETWEEN THE ROD AND THE TERMINAL IS BROKEN AND IN ADDITION THE ROD THREADED PART IS BROKEN INSIDE THE TERMINAL. IT SEEMS THAT DURING USAGE THE WELDING PART HAS BEEN BROKEN BY TRANSFERRING THE LOAD DURING HAMMER BLOWS ON THE ROD. THIS CAUSED THE BREAKAGE OF THE ROD PART. IN ADDITION, THE THREADED TERMINAL PART IS SCRATCHED. IT SEEMS THAT DURING REPEATED USAGE THIS PART HAS BEEN RUINED. THE INSTRUMENT HAS BEEN ON THE MARKET SINCE 2011.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 DECEMBER 2017. LOT 1110481: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 SEPT 2011. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT.

    Description of Event or Problem · 1

    THE VERSAFITCUP CC CUP IMPACTOR WAS SCREWED INTO THE CUP: DURING IMPACTION, THE TERMINAL PART OF THE INSTRUMENT DETACHED FROM THE HANDLE. IT WAS POSSIBLE TO SEPARATE IT FROM THE CUP AS THE IMPLANT WAS NOT YET FIXED INTO THE ACETABULUM. A SECONDARY INSTRUMENT, SAME REFERENCE, WAS AVAILABLE IN THE SECOND SET PRESENT IN THE OR AND IT WAS USED TO IMPACT THE DEFINITIVE CUP. SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903124 VERSAFITCUP CC CUP IMPACTOR SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1110481

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other