BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-DRIVE III CONSOLE

    MDR report key: 6992738 · Received November 1, 2017

    Report

    Report Number
    0001825034-2017-09825
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    October 2, 2017
    Report Date
    December 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JXE
    PMA / PMN Number
    PK031280
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS ZIMMER BIOMET DOES NOT HOLD THE REPORTABILITY FOR THIS PRODUCT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-09829 . NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL ELBOW REVISION THE ULTRA DRIVE WAS NOT WORKING. THE R PEDAL WOULD NOT ACTIVATE, AND THE PEDAL WAS CHANGED. THERE WAS NO DIFFERENCE. ONCE THE CONSOLE WAS CHANGED, THE ULTRA DRIVE FUNCTIONED PROPERLY. THE PROCEDURE WAS DELAYED FOR 45 MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773710 ULTRA-DRIVE III CONSOLE DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT JXE ZIMMER BIOMET, INC. N/A 25135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other