BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 6449454 · Received March 31, 2017

    Report

    Report Number
    3005180920-2017-00149
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    March 3, 2017
    Report Date
    March 31, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 27 MARCH 2017. LOT 1550781: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 NOVEMBER 2015. 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 52, CODE 01.26.45.0052, LOT. 162922 (K103352) LOT 162922: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 JULY 2016. EXPIRATION DATE: 2021-07-11. 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. ON 27 MARCH 2017, THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THE TERMINAL WAS STUCK IN THE CUP, IT WAS NECESSARY TO BLOCK THE CUP IN A CLAMP TO DISASSEMBLY THE PIECES. WE APPLIED A LOW EFFORT TO UNLOCK THE TERMINAL FROM THE CUP. THERE WAS SOME COAGULATED BLOOD BETWEEN THE THREADS OF THE PIECES. IT MIGHT BE POSSIBLE THAT COAGULATED BLOOD BLOCKED THE CUP BUT WE DO NOT KNOW IF IT HAPPENED DURING THE SURGERY.

    Description of Event or Problem · 1

    THE TERMINAL CUP IMPACTOR FOR METAL BACK CC STUCK INTO THE CUP AND CAN'T BE DISCONNECT. THE SURGEON USED A NEW CUP (SAME REFERENCE) TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232165 TERMINAL CUP IMPACTOR FOR METAL BACK CC SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1550781

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other