BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 71MM

    MDR report key: 8119443 · Received November 30, 2018

    Report

    Report Number
    0001825034-2018-10921
    Event Type
    Injury
    Date Received
    November 30, 2018
    Report Date
    August 8, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI# (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION FROM THE CUSTOMER. PRIMARY OPERATIVE NOTES PROVIDED STATE THAT THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELEVANT DEVIATIONS / ANOMALIES IDENTIFIED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE: UNKNOWN DATE IN (B)(6) 2018. THERAPY DATE: UNKNOWN DATE IN (B)(6) 2018. CONCOMITANT MEDICAL PRODUCTS: VANGUARD PS FEMORAL, CATALOG #: 183104, LOT #: J3642784, VANGUARD PS TIBIAL BEARING, CATALOG #: 183642, LOT #: 081060, SERIES A PATELLA, CATALOG #: 184784, LOT #: 503700, PALACOS RG, CATALOG #: 00111314001, LOT #: 86004593. CUSTOMER HAS INDICATED PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. INVESTIGATION IS IN PROCESS. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10921, 0001825034-2018-10922. 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. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A PROCEDURE TO REMOVE SCAR TISSUE AND EXPERIENCED INFLAMMATION, SWELLING, AND WARM TO THE TOUCH. PATIENT ALLEGES POSSIBLE METAL ALLERGY AND WILL UNDERGO FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958707 BIOMET CC CRUCIATE TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6035794

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R