BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PATELLA

    MDR report key: 7766714 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07498
    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
    JWH
    PMA / PMN Number
    PN/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 CR ILOK FEM CAT: 183028 LOT: UNK; VNGD CR TIB BRG CAT: 183444 LOT: UNK; BIOMET CC I-BEAM TRAY CAT: 141223 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. NO PRODUCT 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
    609265 UNKNOWN PATELLA KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R