BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VANGUARD TIBIAL BEARING 10MM

    MDR report key: 2233418 · Received September 2, 2011

    Report

    Report Number
    1825034-2011-00782
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K080528
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, (B)(4) STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION/LOOSENING, MIGRATION/SUBSIDENCE, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2011, DUE TO FRACTURE OF THE TIBIAL BEARING. THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E1 VANGUARD TIBIAL BEARING 10MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 206850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R