BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRID OFFSET SHELL INSERTER

    MDR report key: 5566463 · Received April 10, 2016

    Report

    Report Number
    1822565-2016-00999
    Event Type
    Malfunction
    Date Received
    April 10, 2016
    Date of Event
    February 23, 2016
    Report Date
    March 22, 2016
    Manufacturer
    ZIMMER INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE HYBRID OFFSET SHELL INSERTER, HYBRID PROVISIONAL SHELL ADAPTOR THIMBLE, AND BALL HEX SCREWDRIVER WERE RETURNED FOR REVIEW. VISUAL INSPECTION REVEALS THAT THE INSERTER SHOWS SIGNS OF WEAR AND TEAR, SUGGESTING EXTENSIVE USE. THE FREQUENCY OF USE OF THIS INSTRUMENT IS UNKNOWN. THE LEADING THREADS ON THE INSERTER HEX BOLT ARE DAMAGED AND WILL NOT ACCEPT THREAD GO GAUGE 25-2003-304-00J. THE DEVICE WILL NO LONGER FUNCTION AS INTENDED. THE SHELL INSERTER HAS A POTENTIAL FIELD AGE IS APPROXIMATELY 5 YEARS AND 10 MONTHS BASED ON MANUFACTURING DATE. REVIEW OF RECEIVING INSPECTION REPORTS INDICATES THE DEVICES WERE MANUFACTURED TO SPECIFICATIONS. INSPECTION DOCUMENTATION SHOWS ALL DEVICES THAT WERE INSPECTED MET SPECIFICATIONS. THE REPORTED DEVICES ARE USED FOR TREATMENT. IT IS NOT KNOWN IF THE DEVICE WAS USED WITH THE CORRECT ADAPTOR CAP, AND THERE ARE NO OBVIOUS SIGNS OF MISUSE. THEREFORE, WITH THE INFORMATION PRESENTED, IT IS LIKELY THAT THE LEAD THREAD DAMAGE IS A RESULT OF NORMAL WEAR DURING THE INSTRUMENT¿S FIELD LIFE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER INSPECTION AND FUNCTIONAL TESTING, "IF DAMAGE OR WEAR IS NOTED THAT MAY COMPROMISE THE FUNCTION OF THE INSTRUMENT, DO NOT USE THE DEVICE."

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ACETABULAR SHELL INSERTER WOULD NOT LOCK INTO THE SHELL DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221741 HYBRID OFFSET SHELL INSERTER LXH LXH ZIMMER INC 61532172

    Patients

    Seq Age Sex Outcome Treatment
    1