BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN KNEE

    MDR report key: 6964390 · Received October 20, 2017

    Report

    Report Number
    0001825034-2017-09222
    Event Type
    Death
    Date Received
    October 20, 2017
    Report Date
    October 18, 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
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT- (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER AND LOT NUMBER OF THE DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. PEARSE, A. J., HOOPER, G. J., ROTHWELL, A., & FRAMPTON, C. (2010). SURVIVAL AND FUNCTIONAL OUTCOME AFTER REVISION OF A UNICOMPARTMENTAL TO A TOTAL KNEE REPLACEMENT. THE JOURNAL OF BONE & JOINT SURGERY, 92-B, 508-512. DOI:10.1302/0301-620X.92B4. 22659 .

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "SURVIVAL AND FUNCTIONAL OUTCOME AFTER REVISION OF A UNICOMPARTMENTAL TO A TOTAL KNEE REPLACEMENT." THIS ARTICLE IDENTIFIED AT MEAN FOLLOW-UP TIME OF 2.81 YEARS (0.085 TO 7.83) TEN (10) PATIENTS WHO UNDERWENT REVISION OF UNICOMPARTMENTAL KNEE REPLACEMENTS HAD DIED FOR UNKNOWN REASONS. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744383 UNKNOWN KNEE KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death