BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-DRIVE III CONSOLE

    MDR report key: 6977606 · Received October 25, 2017

    Report

    Report Number
    0001825034-2017-09685
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    January 22, 2016
    Report Date
    October 25, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JXE
    PMA / PMN Number
    PK031280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. PROBLEM WAS INTERMITTENT AND COULD NOT BE ISOLATED. THIS TIME, THE PROBLEM WAS ISOLATED TO A LOOSE GROUND CONNECTION. AGE AND HANDLING ARE A POSSIBLE CAUSE OF THE LOOSE CONNECTION. ACETABULAR GOUGE COMING OUT OF ONE SIDE, WOULD NOT ALLOW POWER AMP TO FUNCTION. ALSO FOUND 2 BROKEN RESISTORS IN THE PHASE FEEDBACK CAUSED DEVICE NOT TO FUNCTION. DEVICE REPAIRED AND RETURNED TO CUSTOMER BY SUPPLIER. REPLACED BROKEN RESISTORS TO RESTORE PHASE FEEDBACK FUNCTION. REPLACED ACETABULAR COMPONENT TO RESTORE PROPER FUNCTION OF THE HAND PIECE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION: UNDER SECTION 6. TROUBLESHOOTING: IF THE LIKELY SOLUTIONS FAIL TO CORRECT THE PROBLEM, CONTACT ULTRA-DRIVE 3 CUSTOMER SERVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INTERMITTENT PROBLEM WITH THE ULTRA DRIVE III CONSOLE ON (B)(6) 2016 DURING A REVISION OF A COMPETITOR REVERSE SHOULDER. THE ROOT CAUSE WAS ATTRIBUTED TO A LOOSE GROUND WIRE CONNECTION. THE HUMERAL STEM WAS REMOVED WITH CHISELS AND HUMERAL EXTRACTION INSTRUMENT AND A ZIMMER BIOMET HUMERAL IMPLANT WAS CEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756650 ULTRA-DRIVE III CONSOLE DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT JXE ZIMMER BIOMET, INC. N/A 25372

    Patients

    Seq Age Sex Outcome Treatment
    1