BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS CUP IMPACTOR TERMINAL-M10

    MDR report key: 14787360 · Received June 23, 2022

    Report

    Report Number
    3005180920-2022-00481
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    May 23, 2022
    Report Date
    July 19, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040736015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: LOOKING AT THE IMAGE ATTACHED TO THE COMPLAINT IT IS VISIBLE THAT THE TERMINAL IS BLOCKED INSIDE THE CUP. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CASUE EVEN IF IT IS POSSIBLE THAT THE INSTRUMENT BALINIT COATING IS SCRATCHED AND THIS CAUSED THE COLD WELDING WITH THE CUP. BATCH REVIEW PERFORMED ON 17 JUNE 2022: LOT 2053947: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JULY-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON 01 JUNE 2022 ON CUP VERSAFITCUP CC TRIO 01.26.45.0054 ACETABULAR SHELL CC TRIO Ø 54 (K103352) LOT. 2112747: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2021. EXPIRATION DATE: 2026-11-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. DURING THE ANALYSIS IT IS EVALUATED THAT THE BALINIT COATING ON THE INSTRUMENT BODY IS SCRATCHED AND SOME SINGS ARE PRESENT. SOME COATING SINGS ARE PRESENT ALSO ON THE CUP BODY. THE SCRATCHED OF THE BALINIT COATING SHOULD BE THE CAUSE OF THE REPORTED COLD WELDING WITH THE CUP.

    Description of Event or Problem · 0

    TERMINAL FOR CUP IMPACTOR AND VERSAFITCUP CC TRIO COLD WELDING DURING THE SURGERY, A BACK UP SHELL OF THE SAME SIZE WAS OPEN AND USED WITHOUT SUCCESS BECAUSE THE PRESS FIT IN THE BONE WASN'T GOOD. DUE TO THIS AN ADDITIONAL ACETABULAR BONE REAMING WAS NECESSARY AND A NEW CUP SIZE 56 WAS FINALLY IMPLANTED WITH SUCCESS. 1,30H DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267214 AMIS CUP IMPACTOR TERMINAL-M10 SURGICAL INSTRUMENT FOR HIP SURGERY LXH MEDACTA INTERNATIONAL SA 01.15.10.0263 2053947 07630040736015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other