BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 4707571 · Received April 9, 2015

    Report

    Report Number
    3005180920-2015-00052
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 10, 2015
    Report Date
    April 9, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07/02/2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT AND IN THE FIRST FOLLOW UP. ON 07/09/2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ON 04/20/2015 THE RETRIEVED ITEMS HAVE BEEN DISASSEMBLED AND THE LOT OF THE INSTRUMENT HAS BEEN DETECTED: 1213128. ON THIS DATE, THE R AND D PROJECT MANAGER ANALYZED THE ITEMS WITH THE FOLLOWING OUTCOMES: THE TERMINAL WAS BLOCKED INTO THE CUP BECAUSE THE THREAD WAS DAMAGED LIKELY DUE TO A HIT. THE DAMAGED THREAD COMPROMISES THE COUPLING WITH THE CUP.

    Additional Manufacturer Narrative · 1

    THE LOT OF THE INSTRUMENT IS UNK AND WE ARE WAITING FOR THE RETRIEVED ITEMS TO MAKE IT AVAILABLE. BATCH REVIEW PERFORMED ON 04/09/2015 ON THE LOT OF THE SHELL: LOT 145994: (B)(4) SHELLS PRODUCED AND RELEASED ON 11/17/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) SHELLS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR ISSUE.

    Description of Event or Problem · 1

    IMP REF#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233733 TERMINAL CUP IMPACTOR FOR METAL BACK CC SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other VERSAFITCUP CC TRIO ACETABULAR SHELL:| K103352, CODE: 01.26.45.0058, LOT: 145994