BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BEARING

    MDR report key: 8222355 · Received January 7, 2019

    Report

    Report Number
    0001822565-2018-07101
    Event Type
    Injury
    Date Received
    January 7, 2019
    Report Date
    January 7, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWJ
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS NOT REVISED AND THE DEVICE(S) REMAIN IN-VIVO. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS INDICATED FOR A REVISION TO ADDRESS BUSHING WEAR. THE REVISION WAS CANCELLED INDEFINITELY DUE TO PATIENT NON-COMPLIANCE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14306 UNKNOWN BEARING PROSTHESIS, EXTREMITY KWJ ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other