BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-LT 65

    MDR report key: 7767472 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07527
    Event Type
    Injury
    Date Received
    August 9, 2018
    Report Date
    August 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    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). MEDICAL PRODUCT: VNGD CR TIB BRG 14X71/75, CAT#: 183444; BIOMET CC I-BEAM TRAY 71MM, CAT#: 141223; UNKNOWN VANGUARD PATELLA. 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: 0001825034-2018-07527; 0001825034-2018-07529; 0001825034-2018-07530; 0001825034-2018-07532. 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 A PATIENT UNDERWENT PRIMARY TOTAL KNEE ARTHROPLASTY, HOWEVER THE PATIENT EXPERIENCED COMPLICATIONS POST-OPERATIVELY. THE COMPLICATIONS INCLUDED: RENAL INSUFFICIENCY, OLIGURIA, NSVT, CONFUSION, HYPOKALEMIA, ENTEROCOCCUS BACTEREMIA, HYPOTENSION, ANEMIA, ENCEPHALOPATHY, BLOOD CLOT AND EXTENDED HOSPITAL STAY OF FIVE (5) WEEKS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607730 VANGUARD CR ILOK FEM-LT 65 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R