BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN AFFIXUS NAIL

    MDR report key: 6963298 · Received October 19, 2017

    Report

    Report Number
    0001825034-2017-08875
    Event Type
    Death
    Date Received
    October 19, 2017
    Date of Event
    September 28, 2016
    Report Date
    October 26, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: UNKNOWN, TRAUMA SCREW, UNKNOWN. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). REPORT SOURCE, LITERATURE - CORDERO, J. ET AL (2016). SURGICAL DELAY AS A RISK FACTOR FOR WOUND INFECTION AFTER A HIP FRACTURE. INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, 47(3), 56-60. DOI: 10.1016/S0020-1383(16)30607-6. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 08876, 0001825034 - 2017 - 08877, 0001825034 - 2017 - 08878.

    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

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT NINETY-SIX PATIENTS DIED UP TO ONE YEAR POSTOPERATIVELY DUE TO DIFFERENT MEDICAL AND/OR SURGICAL COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740284 UNKNOWN AFFIXUS NAIL ROD, FIXATION HSB ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death