BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SERIES-A STANDARD PATELLA

    MDR report key: 7498717 · Received May 9, 2018

    Report

    Report Number
    0001825034-2018-03266
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    March 13, 2018
    Report Date
    May 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2018-02482, 0001825034-2018-02483, 0001825034-2018-02481. CONCOMITANT MEDICAL PRODUCTS: N PS CLSD INTLK FEM-RT 65 CAT: 183208 LOT: 593230, VNGD PS+ TIB BRG 12X63/67MM CAT: 183722 LOT: 749490, BIOMET CC CRUCIATE TRAY 67MM CAT: 141232 LOT: J3942087. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340210 VANGUARD SERIES-A STANDARD PATELLA KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. 918900

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R