BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP CC TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 7560669 · Received June 1, 2018

    Report

    Report Number
    3005180920-2018-00393
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 3, 2018
    Report Date
    June 1, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 JUNE 2018: LOT 1213128: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 FEBRUARY 2013. NO ANOMALIES FOUND RELATED TO THE ISSUE. A SIMILAR EVENT ON THE SAME LOT REGISTERED UP TO NOW. VISUAL INSPECTION PERFORMED ON 29 MAY 2018 BY R&D PRODUCT MANAGER: DURING THE ANALYSIS IT IS EVALUATED THAT THE TERMINAL IS BLOCKED INSIDE THE CUP. WE HAVE DISLOCATED THE TERMINAL FROM THE CUP USING THE SCREWDRIVER REF (B)(4). LOOKING AT THE THREADED PART OF THE TERMINAL WE EVALUATED THAT THE TIP PART IS LITTLE BIT DEFORMED. IN ADDITION THE BALINIT-C COATING IS SCRATCHED. ALSO ON THE CUP THERE ARE SOME RESIDUAL OF BALINIT-C. IT SEEM THAT THE SURGEON NOT SCREWED CORRECTLY THE TERMINAL IN THE CUP BEFORE IMPACTION AND THIS CAUSED THE DEFORMATION OF THE THREADED TIP TOGETHER WITH THE SCRATCHED OF THE BALINIT-C COATING.

    Description of Event or Problem · 1

    THE TERMINAL CUP IMPACTOR STUCK INTO THE CUP AND CAN'T BE DISCONNECTED. THE SURGEON USED ANOTHER CUP AND THE LONG STRAIGHT MULTIFUNCTION HANDLE TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403216 VERSAFITCUP CC TERMINAL CUP IMPACTOR FOR METAL BACK CC SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1213128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other