BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN KNEE

    MDR report key: 6966444 · Received October 20, 2017

    Report

    Report Number
    0001825034-2017-09452
    Event Type
    Death
    Date Received
    October 20, 2017
    Report Date
    October 20, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    NRA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 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. LITERATURE: KAJ, K., & L. (1986). SURVIVAL OF KNEE ARTHROPLASTIES. BRITISH EDITORIAL SOCIETY OF BONE AND JOINT SURGERY, 68(B), 5TH SER., 795-803. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "SURVIVAL OF KNEE ARTHROPOLASTIES. A NATION-WIDE MULTICENTRE INVESTIGATION OF 8000 CASES" WHICH ASSESSED THE SURVIVABILITY OF KNEE ARTHROPLASTIES. THIS COMPLAINT ADDRESSES THE FOUR HUNDRED NINETY-EIGHT (498) PATIENTS DEATHS DUE TO UNKNOWN REASONS. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745467 UNKNOWN KNEE PROSTHESIS KNEE NRA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death