BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 7344707 · Received March 16, 2018

    Report

    Report Number
    3005180920-2018-00158
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Date of Event
    February 8, 2018
    Report Date
    March 16, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 MARCH 2018: AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC REFERENCE LOT. 1413789 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE FIFTH SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT VERSAFITCUP CC ACETABULAR SHELL CC TRIO Ø 58 REFERENCE (B)(4) (K103352) LOT 162340: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016; EXPIRATION DATE: 2021-06-23. NO ANOMALY FOUND RELATED TO THE ISSUE. 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 THE FINAL CUP IMPACTION THE TERMINAL FOR AMIS CUP IMPACTOR REMAINED STUCK IN THE IMPLANT. THE SURGEON WAS ABLE TO REMOVE THE ASSEMBLY AND TO IMPLANT A BACK-UP SHELL OF THE SAME SIZE USING THE LINER IMPACTION SPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188025 AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC MANUAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1413789

    Patients

    Seq Age Sex Outcome Treatment
    1 Other