BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ZIMMER NEXGEN TIBIAL TRAY

    MDR report key: 6776296 · Received August 9, 2017

    Report

    Report Number
    0001822565-2017-05515
    Event Type
    Death
    Date Received
    August 9, 2017
    Date of Event
    December 10, 2015
    Report Date
    August 8, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-05513, 0001822565-2017-05514. MEDICAL PRODUCTS ¿ UNKNOWN ZIMMER NEXGEN BEARING CATALOG # UNKNOWN, LOT # UNKNOWN, UNKNOWN ZIMMER NEXGEN FEMORAL COMPONENT CATALOG # UNKNOWN, LOT # UNKNOWN. INITIAL REPORTER: CLAIRE TILBURY, MD, TSJITSKE M. HAANSTRA, MSC, PHD B, CLAUDIA S. LEICHTENBERG, BSC SUZAN H.M. VERDEGAAL, MDC, RAYMOND W. OSTELO, PHD, HENRICA C.W. DE VET, PHD ROB G.H.H. NELISSEN, MD, PHD A, THEA P.M. VLIET VLIELAND, MD, PHD UNFULFILLED EXPECTATIONS AFTER TOTAL HIP AND KNEE ARTHROPLASTY SURGERY: THERE IS A NEED FOR BETTER PREOPERATIVE PATIENT INFORMATION AND EDUCATION¿ 31 (2016) 2139-2145. (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED,A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT OF 322 TOTAL KNEE ARTHROPLASTIES PATIENTS WITH COMPLETE FOLLOW-UP THAT FOUR (4) PATIENTS WERE DECEASED AFTER 1 YEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560631 UNKNOWN ZIMMER NEXGEN TIBIAL TRAY PROSTHESIS, KNEE MBH ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death