BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM PS PLUS 14MM X 79/83MM TIBIAL BEARING

    MDR report key: 2123019 · Received June 14, 2011

    Report

    Report Number
    1825034-2011-00508
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K041046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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, NUMBER SIX STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011, DUE TO SEVERE FIBROSIS AND LACK OF FLEXION. THE 14MM X 79/83MM TIBIAL BEARING WAS REMOVED AND REPLACED WITH A 12MM X 79/83MM TIBIAL BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD DCM PS PLUS 14MM X 79/83MM TIBIAL BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 091060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R