BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN VERSA NAIL

    MDR report key: 6961529 · Received October 19, 2017

    Report

    Report Number
    0001825034-2017-09089
    Event Type
    Death
    Date Received
    October 19, 2017
    Date of Event
    April 14, 2017
    Report Date
    November 3, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KTT
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). REPORT SOURCE, LITERATURE - ARMSTRONG, L. ET AL (2017). TIBIOTALOCALCANEAL NAIL FIXATION AND SOFT TISSUE COVERAGE OF GUSTILO¿ANDERSON GRADE 3B OPEN UNSTABLE ANKLE FRACTURES IN A FRAIL POPULATION; A CASE SERIES IN A MAJOR TRAUMA CENTRE. FOOT AND ANKLE SURGERY, 1-6. DOI: 10.1016/J.FAS.2017.03.015. 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. 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. 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 WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT WITH A HISTORY OF DIABETES DIED AFTER SURGERY. THE CAUSE OF DEATH IS UNKNOWN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740901 UNKNOWN VERSA NAIL FIXATION, NAIL KTT ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death