BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 6746479 · Received July 27, 2017

    Report

    Report Number
    3005180920-2017-00412
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    June 29, 2017
    Report Date
    July 27, 2017
    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 REVIEWS PERFORMED ON 25 JULY 2017. LOT 1653999: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 FEBRUARY 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, OTHER (B)(4) SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT (COMPLAINTS (B)(4)). VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 48, CODE 01.26.45.0048, LOT. 168164 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 APRIL 2017. EXPIRATION DATE: 2022-03-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 27 JULY 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THIS VISUAL INSPECTION IS RELATED TO ACETABULAR SHELL AND TERMINAL CUP IMPACTOR. THE TERMINAL IS SCREWED AND FIXED INSIDE THE CUP. WE HAVE UNSCREWED IT USING THE NEW SCREWDRIVER IN COMBINATION WITH ROD. LOOKING AT THE TERMINAL SUFACE WE NOTICE THAT THE BALINIT-C COATING IS SLIGHTLY SCRATCHED TOGETHER WITH THE THREADED CONNECTION TIP. ALSO ON THE IMPLANTS WE NOTICED BALINIT-C FRAGMENTS AND THREADED HOLE SCRATCHES. THESE SHOULD BE THE ROOT CAUSE OF THE COMPLAINTS.

    Description of Event or Problem · 1

    DURING SURGERY, THE TERMINAL CUP IMPACTOR FOR METAL BACK CC STUCK INTO THE CUP AND CAN'T BE DISCONNECT. THE SURGEON USED ANOTHER CUP (SAME REF.) TO COMPLETE THE SURGERY. THE SURGEON COMPLETED THE SURGERY WITH THE CUP IMPACTOR WITH M30NW TERMINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529293 AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1653999

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other