BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOMET ARCOM PATELLA

    MDR report key: 8050990 · Received November 8, 2018

    Report

    Report Number
    0001825034-2018-08375
    Event Type
    Death
    Date Received
    November 8, 2018
    Date of Event
    January 16, 2014
    Report Date
    August 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 141236, BIOMET CC CRUCIATE TRAY, LOT # 485830; CATALOG #: 183132, VANGUARD PS INTERLOCKING FEMORAL, LOT # 766450; CATALOG #: 183666, VANGUARD PS TIBIAL BEARING, LOT # 880960. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. 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: 0001825034-2018-08372, 0001825034-2018-08373, 0001825034-2018-08374, 0001825034-2018-08375, 0001825034-2018-04819, 0001825034-2018-04837, 0001825034-2018-04845, 0001825034-2018-04846. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPIRED EIGHT YEARS POST IMPLANTATION DUE TO UNKNOWN REASON. THERE ARE NO COMPLICATIONS NOTED WITHIN THE STUDY FOR THIS PATIENT AND THERE IS NO INDICATION THE DEATH WAS PRODUCT OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889455 BIOMET ARCOM PATELLA PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 038760

    Patients

    Seq Age Sex Outcome Treatment
    1 Death