BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN AGC TIBIAL TRAY

    MDR report key: 6816297 · Received August 24, 2017

    Report

    Report Number
    0001825034-2017-06705
    Event Type
    Death
    Date Received
    August 24, 2017
    Date of Event
    May 22, 2017
    Report Date
    August 24, 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: JOHN B. MEDING, PHILIP M. FARIS, KEN E. DAVIS ¿ BILATERAL TOTAL HIP AND KNEE ARTHROPLASTIES: AVERAGE 10-YEAR FOLLOW-UP¿ THE JOURNAL OF ARTHROPLASTY (2017) 1-5. 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: 0001825034-2017-06703, 0001825034-2017-06704, 0001825034-2017-06706.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A TOTAL OF FORTY-SIX PATIENTS HAD EXPIRED DURING THE COURSE OF THE STUDY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596926 UNKNOWN AGC TIBIAL TRAY PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death