BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 6249489 · Received January 13, 2017

    Report

    Report Number
    3005180920-2016-00736
    Event Type
    Malfunction
    Date Received
    January 13, 2017
    Date of Event
    December 15, 2016
    Report Date
    January 13, 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

    ON 12 JANUARY 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: TERMINAL CUP IMPACTOR FOR METAL BACK CC WAS STUCK IN VERSAFIT CUP METALBACK CC TRIO Ø 46. WE NEEDED OF A HEXAGONAL KEY TO DISASSEMBLY THE TERMINAL. THE BALIT C COVERING WAS ALMOST ABSENT ON THE SURFACE OF THE CONTACT WITH CUP. THIS IS THE ROOT CAUSE OF THE FAILURE. BATCH REVIEWS PERFORMED ON 13 JANUARY 2017. LOT 1651156: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 JULY 2016. 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 46, CODE 01.26.45.0046, LOT. 147712 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 FEBRUARY 2015. EXPIRATION DATE: 2020-01-31. 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. DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE TERMINAL CUP IMPACTOR FOR METAL BACK CC, STUCK IN VERSAFIT CUP METALBACK CC TRIO Ø 46, CAN'T BE DISCONNECTED. THE SURGEON TOOK A NEW VERSAFIT CUP METALBACK CC TRIO Ø 46 AND IMPACTED IT WITH THE STRAIGHT IMPACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34811 TERMINAL CUP IMPACTOR FOR METAL BACK CC SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1651156

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other