BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 POSITIONING GUIDE ROD

    MDR report key: 8164809 · Received December 14, 2018

    Report

    Report Number
    0001825034-2018-11261
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 15, 2018
    Report Date
    May 8, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION OF THE GUIDE ROD CONFIRMED THE HEAD TO HAVE FRACTURED FROM THE REMAINDER OF THE DEVICE. THE ROD REMAINS ASSEMBLED WITH THE INSERTER, GUIDE POST, AND LATERAL FRAME. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 110003453, ITEM NAME: G7 CURVED ACET SHELL INSERTER, LOT #: 256090, ITEM NUMBER: 110018823, ITEM NAME: G7 POSITIONING GUIDE POST, LOT #: ZB160702, ITEM NUMBER: 110003456, ITEM NAME: G7 LATERAL POSITIONING GUIDE, LOT #: ZB161007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING WAREHOUSE INSPECTION IT WAS NOTED THAT THE INSTRUMENT HAD FRACTURED AND WAS UNABLE TO BE TAKEN APART. NO PATIENT IMPACT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003467 G7 POSITIONING GUIDE ROD INSTRUMENT , HIP LXH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1