BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET ARCOM 3 PEG PATELLA

    MDR report key: 7762626 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06805
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    December 5, 2007
    Report Date
    August 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    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 FEMUR CATALOG 183008 LOT UNKNOWN, VANGUARD TIBIAL BEARING CATALOG 183441 LOT UNKNOWN, BIOMET I-BEAM TIBIAL TRAY CATALOG 141223 LOT UNKNOWN. 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: 0001825034-2018-06801, 0001825034-2018-06803, 0001825034-2018-06804, 0001825034-2018-06805. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOTED TO HAVE CELLULITIS APPROXIMATELY NINE MONTHS POST RIGHT TOTAL KNEE ARTHROPLASTY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601756 UNKNOWN BIOMET ARCOM 3 PEG PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR