BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERMINAL CUP IMPACTOR FOR METAL BACK CC

    MDR report key: 4730652 · Received April 22, 2015

    Report

    Report Number
    3005180920-2015-00065
    Event Type
    Malfunction
    Date Received
    April 22, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 APRIL 2015: LOT 095874: (B)(4) TERMINALS PRODUCED AND RELEASED ON 30 NOVEMBER 2009. NO ANOMALIES FOUND RELATED TO THE ISSUE. LOT 132221: (B)(4) SHELLS PRODUCED AND RELEASED ON 05 AUGUST 2013. NO ANOMALIES FOUND RELATED TO THE PRODUCT. TO DATE, (B)(4) SHELLS OF THE LOT HAVE BEEN ALREADY SOLD. ON 22ND APRIL THE R AND D PROJECT MANAGER MADE THE FOLLOWING ANALYSIS UPON INSPECTION OF THE RETRIEVED ITEMS: THE DEVICES COULD NOT BE SEPARATED MANUALLY, THEREFORE A CLAMP WAS USED IN ORDER TO DISENGAGE THE TERMINAL FROM THE METAL BACK. AFTER RELEASE, IT WAS NOTICED THAT THE CONTACT SURFACE OF THE METAL BACK IS SEVERELY RUINED DUE TO THE FRICTION BETWEEN THE TERMINAL AND THE METAL BACK. THE TERMINAL GOT STUCK IN THE METAL BACK PROBABLY DUE THE HIGH FRICTION BETWEEN THE TWO DEVICES DURING IMPACTION LEADING TO TA COLD WELDING EVENT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268050 TERMINAL CUP IMPACTOR FOR METAL BACK CC SURGICAL INSTRUMETN FOR HIP LXH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other