BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOMET CC I-BEAM TRAY

    MDR report key: 7754219 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-04879
    Event Type
    Death
    Date Received
    August 6, 2018
    Date of Event
    October 24, 2010
    Report Date
    August 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD PS OPEN BOX FEMORAL INTERLOK, CATALOG # 183128, LOT # UNKNOWN. VANGUARD DCM PS PLUS TIBIAL BEARING, CATALOG # 183746, LOT # UNKNOWN, UNKNOWN VANGUARD PATELLA, CATALOG # UNKNOWN, LOT # UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) 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. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2018-04882, 0001825034-2018-04884, 0001825034-2018-04887.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS FOUND EXPIRED IN THE EXTENDED CARE FACILITY THREE DAYS POST IMPLANTATION. ETIOLOGY IS UNKNOWN; HOWEVER THERE IS NO INDICATION THE CAUSE OF DEATH WAS RELATED TO THE PROCEDURE OR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594651 BIOMET CC I-BEAM TRAY KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death