BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 6224856 · Received January 5, 2017

    Report

    Report Number
    3005180920-2016-00711
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Date of Event
    December 7, 2016
    Report Date
    February 3, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 18 JANUARY 2017 THE (B)(6) PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: ACCORDING TO OUR VISUAL INSPECTION THERE IS IMPINGEMENT BETWEEN : TEETH OF THE CUP AND THE TERMINAL RIM. INTERNAL SURFACE OF THE CUP AND BOTTOM OF THE CUP IMPACTOR. FOR THIS REASON, THESE INSTRUMENT ARE NOT COMPATIBLE WITH VERSAFIT CUP TG. 42. THIS CUP CAN BE IMPLANTED USING PRECIMED/GREATBATCH/HPF AMIS CUP IMPACTOR.

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 29 DECEMBER 2016. LOT. 1311795: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 SEPTEMBER 2013. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 42, CODE 01.26.45.0042, LOT. 146525 (K122911) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 NOVEMBER 2014. EXPIRATION DATE: 2019-10-31. 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. NOT YET ANALYZED.

    Description of Event or Problem · 1

    THE TERMINAL CUP IMPACTOR AND OFFSET IMPACTOR JAMMED ONTO THE DEFINITIVE CUP, AND IT WAS THEN UNABLE TO BE RELEASED TO STAY IN SITU. IT HAD TO BE REMOVED, DURING ATTEMPTS BY THE SURGEON TO SEPARATE THE CUP FROM THE INSTRUMENTS, THESE FELL TO THE FLOOR. IT APPEARED THAT THESE INSTRUMENTS ARE NOT COMPATIBLE IN THIS SMALL SIZE, AS MANY SCRATCHES TO THE INTERNAL RIM OF THE CUP OCCURED. AS A RESULT, THIS CUP COULDN'T HAVE BEEN USED ON THE PATIENT, THE SURGEON WENT UP TO A SIZE 44MM CUP WITH HOLES AND USED THE STRAIGHT IMPACTOR WITHOUT ANY ISSUES. NO CRITICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10097 AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1311795

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other