BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 BALL HEX DRVR FOR INSR HNDL

    MDR report key: 7456643 · Received April 24, 2018

    Report

    Report Number
    0001825034-2018-02803
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 26, 2018
    Report Date
    November 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND.. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 0

    NO NEW ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM #010000666, CUP, LOT # 6171963, ITEM # UNK, UNKNOWN IMPACTOR, LOT # UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUP IMPACTOR WOULD NOT DISENGAGE FROM THE CUP. WHILE ATTEMPTING TO SEPARATED THE IMPACTOR AND CUP, THE HEX DRIVER FRACTURED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298350 G7 BALL HEX DRVR FOR INSR HNDL HIP INSTRUMENTATION LXH ZIMMER BIOMET, INC. N/A 489963

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR