BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT THN 31 3 PEG

    MDR report key: 8875101 · Received August 8, 2019

    Report

    Report Number
    0001825034-2019-03498
    Event Type
    Injury
    Date Received
    August 8, 2019
    Report Date
    August 8, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10921, 0001825034-2018-10922, 0001825034-2019-03497. EVENT DATE: UNKNOWN DATE IN (B)(6) 2018. (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD PS FEMORAL, CATALOG #: 183104, LOT #: J3642784. BIOMET CC CRUCIATE TRAY, CATALOG #: 141233, LOT #: J6035794. VANGUARD PS TIBIAL BEARING, CATALOG #: 183642, LOT #: 081060. PALACOS RG, CATALOG #: 00111314001, LOT #: 86004593. CONCOMITANT MEDICAL PRODUCTS: THERAPY DATE: UNKNOWN DATE IN (B)(6) 2018. 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT 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
    670091 SERIES A PAT THN 31 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 503700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R