BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-LT 65

    MDR report key: 7766720 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07491
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    September 13, 2007
    Report Date
    August 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK171054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD CR TIB BRG, CAT: 183444, LOT: UNK; BIOMET CC I-BEAM TRAY, CAT: 141223, LOT: UNK; BIOMET ARCOM 3 PEG/POST ,CAT: UNK, LOT: UNK. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-07491, 0001825034-2018-07496, 0001825034-2018-07497, 0001825034-2018-07498. 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. 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS NOTED TO HAVE PASSED THREE BLOODY STOOLS, AND WAS BLUE FROM TOES UP TO LEFT KNEE REQUIRING ADMISSION TO HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609272 VANGUARD CR ILOK FEM-LT 65 KNEE, PROSTHESIS HRY ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R