BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 6750093 · Received July 28, 2017

    Report

    Report Number
    3005180920-2017-00415
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    June 30, 2017
    Report Date
    July 28, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 25 JULY 2017. LOT 1411056: (B)(4) INSTRUMENTS MANUFACTURED AND RELEASED ON 04 SEPTEMBER 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE SEVENTH SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT. VERSAFITCUP CC TRIO ACETABULAR SHELL NO-HOLE Ø 58, CODE 01.26.45.1158, LOT. 170952 (K122911) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 JUNE 2017. EXPIRATION DATE: 2022-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE ONLY ITEM SOLD OF THIS LOT. ON 28 JULY 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: THE CUP IMPACTOR TERMINAL IS SCREWED AND BLOCKED INSIDE THE IMPLANT CUP. IT IS NECESSARY TO USE A CLAMP TO BE ABLE TO UNSCREW THE TERMINAL. LOOKING AT THE TERMINAL SURFACE SOME SCRATCHES ON THE BALINIT-C HAS BEEN EVALUATED. IN ADDITION THE BALINIT-C FRAGMENTS ARE ALSO PRESENT ON THE IMPLANT SURFACE. MOREOVER DEBRIS OF DRIED BLOOD ARE PRESENT BOTH ON THE TERMINAL AND ON THE IMPLANT SURFACE. BOTH THE BALINIT-C DEGRADATION AND BLOOD DEBRIS COULD BE THE ROOT CAUSE OF THE UNSCREWING BLOCK UNDERLINED IN THIS COMPLAINT.

    Description of Event or Problem · 1

    DURING AN AMIS SURGERY, IT WAS NOT POSSIBLE TO DISCONNECT THE BLACK ADAPTER OF THE OFFSET CUP IMPACTOR FROM THE VERSAFITCUP NO-HOLE SIZE 58MM. THERE WAS A SHORT DELAY IN THE SURGERY TIME BUT NO PATIENT RISK. STRAIGHT CUP IMPACTOR AND A NEW VERSAFTICUP 58MM WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530419 AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1411056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other