BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK AGC KNEE

    MDR report key: 6940094 · Received October 11, 2017

    Report

    Report Number
    0001825034-2017-08309
    Event Type
    Death
    Date Received
    October 11, 2017
    Report Date
    October 9, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY AND COMPLAINT HISTORY REVIEW WAS NOT PERFORMED DUE TO LIMITED INFORMATION PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. LITERATURE: RITTER, M.A, DAVIS, K.E., SMALL, S.R., MERCHUN, J.G. FARRIS, A. TRABECULAR BONE DENSITY OF THE PROXIMAL TIBIA AS IT RELATES TO FAILURE OF A TOTAL KNEE REPLACEMENT (2014) BONE JOINT J 2014;96-B:1503¿9. 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. ZIMMER BIOMET COMPLAINT (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2014 -09017 AND 0001825034 -2017-08300/08303/08304/08306/08307/08308. 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 TITLED, "TRABECULAR BONE DENSITY OF THE PROXIMAL TIBIA AS IT RELATES TO FAILURE OF A TOTAL KNEE REPLACEMENT¿. IT WAS OBSERVED IN THE ARTICLE THAT OUT OF THE 7760 TKRS PERFORMED IN THIS STUDY, 1920 TKRS IMPLANTED IN 1278 PATIENTS DIED DURING THE STUDY. THE REASONS AND DATES FOR PATIENT DEATHS WERE UNKNOWN. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722118 UNK AGC KNEE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death