BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN AGC TIBIAL TRAY

    MDR report key: 6815767 · Received August 23, 2017

    Report

    Report Number
    0001825034-2017-06748
    Event Type
    Death
    Date Received
    August 23, 2017
    Date of Event
    February 4, 2016
    Report Date
    August 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    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

    (B)(4), CONCOMITANT MEDICAL PRODUCT: UNKNOWN AGC FEMORAL COMPONENT, UNKNOWN AGC BEARING, UNKNOWN AGC PATELLA. INITIAL REPORTER: MERRILL A. RITTER, E. MICHAEL KEATING, TATSUYA SUEYOSHI, KENNETH E. DAVIS, JOHN W. BARRINGTON, AND ROGOER H. EMERSON ¿TWENTY-FIVE-YEARS AND GREATER, RESULTS AFTER NONMODULAR CEMENTED TOTAL KNEE ARTHROPLASTY¿ THE JOURNAL OF ARTHROPLASTY 31 (2016) 2199-2202. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06745, 0001825034-2017-06746, 0001825034-2017-06747.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THERE WERE A TOTAL OF THREE THOUSAND FIVE DEATHS, OF WHICH ONE THOUSAND NINETY-NINE WERE WITHIN FIVE YEARS POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595360 UNKNOWN AGC TIBIAL TRAY PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death