BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS 01.15.10.0263 AMIS CUP IMPACTOR TERMINAL-M10

    MDR report key: 8315264 · Received February 7, 2019

    Report

    Report Number
    3005180920-2019-00032
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    December 20, 2018
    Report Date
    February 7, 2019
    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 · 1

    BATCH REVIEW PERFORMED ON 07 FEBRUARY 2019: LOT 1851974: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT. ADDITIONAL COMPONENT INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.0046 ACETABULAR SHELL CC TRIO Ø 46 (K103352), LOT 185442: 80. ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2018. EXPIRATION DATE: 2023-09-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: DURING THE VISUAL INSPECTION THE TERMINAL HAS BEEN UNSCREWED FROM THE CUP USING A PRODUCTION JAW WITH MINIMAL TORQUE. ANALYZING THE TERMINAL IT IS VISIBLE THAT THE BALINIT-C COATING ON THE THREADED PART IS SCRATCHED AND ALSO ON THE CUP SOME SCRATCHES ARE PRESENT. IT IS POSSIBLE THAT DURING THE IMPACTION THE BALINIT-C COATING HAS BEEN DETACHED AND THIS CAUSED THE SCREW FIXATION ON THE CUP.

    Description of Event or Problem · 1

    DURING THE SURGERY THE TERMINAL FOR CUP IMPACTION REMAINED BLOCKED IN THE CUP. THE SURGEON DIDN'T HAVE THE 01.15.10.0293 SCREWDIRVER WITH T-HANDLE TO REMOVE THE TERMINAL FROM THE CUP; HE TRIED TO RELEASE THE ADAPTER FOR ABOUT 10 MINUTES. FINALLY THE SURGEON USED A BACK-UP IMPLANT AND INSTRUMENT COMPLETING SUCCESSFULLY THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111639 AMIS 01.15.10.0263 AMIS CUP IMPACTOR TERMINAL-M10 SURGICAL INSTRUMENT FOR HIP SURGERY LXH MEDACTA INTERNATIONAL SA 1851974 07630040736015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other