BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN FEMORAL COMPONENT

    MDR report key: 6970296 · Received October 23, 2017

    Report

    Report Number
    0001822565-2017-07357
    Event Type
    Death
    Date Received
    October 23, 2017
    Report Date
    November 17, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. PATIENT DEATHS WERE NOT RELATED TO A PRODUCT OR PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). 0001822565 - 2017 - 07358, 0001822565 - 2017 - 07359. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PART/LOT, FEMORAL COMPONENT-KNEE; UNKNOWN PART/LOT, TIBIAL TRAY; UNKNOWN PART/LOT, BEARING. REPORT SOURCE: LITERATURE PANNI, A. S., FALEZ, F., D¿APOLITO, R., CORONA, K., PERISANO, C., & VASSO, M. (2017). LONG-TERM FOLLOW-UP OF A NON-RANDOMISED PROSPECTIVE COHORT OF ONE HUNDRED AND NINETY TWO TOTAL KNEE ARTHROPLASTIES USING THE NEXGEN IMPLANT. INTERNATIONAL ORTHOPAEDICS, 41(6), 1155-1162. 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. (B)(4).

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE REPORTED 13 DEATHS. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747603 UNKNOWN FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death