BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 79MM

    MDR report key: 8045932 · Received November 7, 2018

    Report

    Report Number
    0001825034-2018-10329
    Event Type
    Injury
    Date Received
    November 7, 2018
    Date of Event
    December 16, 2003
    Report Date
    November 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    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: 183014 ¿ VANGUARD FEMORAL ¿ UNKNOWN LOT. 183462 ¿ VANGUARD TIBIAL BRIDGE ¿ UNKNOWN LOT. UNKNOWN PATELLA ¿ UNKNOWN PART AND LOT. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 10326; 0001825034 - 2018 - 10327; 0001825034 - 2018 - 10328.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED CELLULITIS APPROXIMATELY 13 DAYS POST RIGHT PRIMARY TOTAL KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888837 BIOMET CC I-BEAM TRAY 79MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other