BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN AFFIXUS NAIL

    MDR report key: 6961585 · Received October 19, 2017

    Report

    Report Number
    0001825034-2017-08920
    Event Type
    Death
    Date Received
    October 19, 2017
    Report Date
    October 26, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 08920. 0001825034 - 2017 - 08921. 0001825034 - 2017 - 08922. 0001825034 - 2017 - 08923. CONCOMITANT PRODUCTS: UNKNOWN TRAUMA SCREW. REPORT SOURCE : FOREIGN. THE EVENT(S) OCCURRED IN (B)(6). ¿SURGICAL DELAY AS A RISK FACTOR FOR WOUND INFECTION AFTER A HIP FRACTURE.¿ INJURY, ELSEVIER, 28 SEPT. 2016, WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S0020138316306076. 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

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    FIFTEEN 15 CASES OF CARDIAC FAILURE AS A MORTALITY MEDICAL COMPLICATION WERE REPORTED IN THE STUDY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741788 UNKNOWN AFFIXUS NAIL ROD, FIXATION KTT ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O