BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOMET CC I-BEAM TIBIAL TRAY 71MM

    MDR report key: 7754163 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-06141
    Event Type
    Death
    Date Received
    August 6, 2018
    Date of Event
    December 3, 2014
    Report Date
    August 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    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 CRUCIATE RETAINING INTERLOK FEMORAL COMPONENT LEFT 62.5, CATALOG #: 183026, LOT #: NI. VANGUARD CRUCIATE RETAINING TIBIAL BEARING 12X71/75 CATALOG #: 183442 LOT #: NI, BIOMET SERIES A STANDARD 3-PEG PATELLA 31MM, CATALOG #: 184764, LOT #: NI. IT IS INDICATED BY THE COMPLAINANT THAT THE DEVICES WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES REMAIN IMPLANTED. THE COMPLAINT SAMPLE WAS NOT EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-06138, 0001825034-2018-06139, 0001825034-2018-06142.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT DIED APPROXIMATELY ONE (1) MONTH FOLLOWING LEFT KNEE ARTHROPLASTY. THE CAUSE OF DEATH REMAINS UNKNOWN AT THIS TIME. ATTEMPTS WERE MADE TO RETRIEVE ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593740 BIOMET CC I-BEAM TIBIAL TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death