BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR TIBIA BEARING 12X79/83

    MDR report key: 2955556 · Received February 11, 2013

    Report

    Report Number
    0001825034-2013-00266
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO AN INFECTION. THE JOINT WAS WASHED OUT AND THE BEARING WAS REMOVED AND REPLACED WITH ANOTHER BIOMET BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58678 VANGUARD CR TIBIA BEARING 12X79/83 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 020130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R