BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER STEM DRIVER

    MDR report key: 6192959 · Received December 21, 2016

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    Report

    Report Number
    0001822565-2016-04755
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 22, 2016
    Report Date
    September 13, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWR
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR DUE TO INCORRECT INSTRUMENT SELECTION. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 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 · 1

    IT IS REPORTED THAT THE PATIENT'S GREATER TROCHANTER WAS FRACTURED DUE TO THE STRAIGHT INSERTER HANDLE CONTACTING THE BONE. THIS CAUSED ABOUT A 15-20 MINUTE DELAY IN THE CASE DUE TO THE NEED TO CABLE THE GREATER TROCHANTER BACK IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844366 ZIMMER STEM DRIVER INSTRUMENT, HIP HWR ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention