BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 6417405 · Received March 20, 2017

    Report

    Report Number
    3005180920-2017-00119
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 14, 2017
    Report Date
    September 26, 2017
    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

    THE EVENT OCCURRED WHILE IMPLANTING A VERSAFITCUP CC TRIO ACETABULAR SHELL NO-HOLE Ø48 MM, CODE 01.26.45.1148, LOT. 165696 (K122911). BATCH REVIEW PERFORMED ON 20 MARCH 2017. LOT 165696: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 DECEMBER 2016. EXPIRATION DATE: 2021-11-28. 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.

    Additional Manufacturer Narrative · 1

    ON 28 AUGUST 2017 DURING A CHECK, IT WAS FOUND OUT THAT THE LOT INVOLVED IN THE COMPLIANT WAS WRONG REPORTED. THE CORRECT LOT INVOLVED, LOOKING ON THE INSTRUMENT RECEIVED BACK THAT WAS STUCK IN THE CUP IS (B)(4). BATCH REVIEW PERFORMED ON 28 AUGUST 2017. LOT 1651156, (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 JULY 2016. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 MAY 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 SIXTH SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT. ON 15 MAY 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: THE INSTRUMENT WAS STUCK IN THE CUP. WE TRIED TO UNLOCK THE TERMINAL CUP FREE HAND BUT IT WAS NOT POSSIBLE. USING A CLAMP THE INSTRUMENT WAS UNLOCKED FROM THE CUP. A COAGULATED BLOOD WAS FOUND BETWEEN THE INSTRUMENT THREAD AND THE CUP THREAD, THIS CAN, POSSIBLY, HAVE INCREASED THE DIFFICULTY TO UNLOCK THE DEVICES. PROBABLY, THE MEDICAL STAFF SCREWED THE INSTRUMENT INTO THE CUP USING THE SCREWDRIVER STRAIGHT AND STAYING AXIAL WITH THE CUP HOLE, WHEN THEN THE SURGEON TRIED TO REMOVE THE TERMINAL CUP FROM THE DEVICE THE EXCESSIVE INCLINATION OF THE HANDLE DID NOT ALLOW TO UNLOCK THE TERMINAL CUP CORRECTLY. THE HYPOTHESIS WAS ALSO CONFIRMED WITH AN INTERNAL TEST: IF THE SCREWDRIVER IS NOT PERFECTLY ALIGNED WITH THE TERMINAL CUP AND THE CUP HOLE, IT IS MOSTLY IMPOSSIBLE TO UNLOCK THE DEVICES.

    Description of Event or Problem · 1

    THE TERMINAL CUP IMPACTOR FOR METAL BACK WAS STUCK IN THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201762 TERMINAL CUP IMPACTOR FOR METAL BACK CC SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1651156

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other