BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 6511309 · Received April 21, 2017

    Report

    Report Number
    3005180920-2017-00199
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    March 24, 2017
    Report Date
    April 21, 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

    ADDITIONAL INFORMATION RECEIVED ON 30 MARCH 2017 AND INCLUDES: THE SURGEON COMPLETED THE SURGERY WITH A DIFFERENT CUP IMPACTOR WITH M30NW TERMINAL. ON 20 APRIL 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THE TERMINAL IS SCREWED INTO THE CUP AND IT IS NOT POSSIBLE TO REMOVE WITH SCREWDRIVER. USING DEDICATED INSTRUMENT IN OUR PRODUCTION WE HAVE UNSCREWED THE TERMINAL: ANALYZING BOTH CUP AND TERMINAL WE SEE THAT THERE ARE SOME SCRATCHES ON THE BALINIT C COATING OF THE TERMINAL AND IN ADDITION, ALSO THE CUP INTERNAL SUFACE IS LITTLE BIT SCRATCHED WITH BLACK SIGNS. IT IS POSSIBLE THAT EXCESSIVE IMPACTION FORCE CAUSED SCRATCHES ON THE BALINIT-C COATING AND CONSEQUENTLY INCREASED FRICTION COEFFICIENT BETWEEN THE TERMINAL AND THE CUP. BATCH REVIEWS PERFORMED ON 21 APRIL 2017. LOT 1550781: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 NOVEMBER 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE (B)(4) SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT (COMPLAINT (B)(4), MDR 2017-00149). VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 52, CODE 01.26.45.0052, LOT. 165395 (K103352), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 DECEMBER 2016. EXPIRATION DATE: 2021-12-01. 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.

    Description of Event or Problem · 1

    DURING SURGERY, THE TERMINAL CUP IMPACTOR FOR METAL BACK CC STUCK INTO THE CUP AND COULDN'T BE DISCONNECT. THE SURGEON USED A NEW CUP (SAME CODE) AND A DIFFERENT CUP IMPACTOR TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294428 TERMINAL CUP IMPACTOR FOR METAL BACK CC SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1550781

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other