BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD ANTERIOR STABILIZED TIBIAL BEARING 12MM X 83MM

    MDR report key: 2060236 · Received April 15, 2011

    Report

    Report Number
    1825034-2011-00280
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 23, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K050222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." EVALUATION OF THE RETURNED COMPONENT FOUND DEFORMATION WHICH IS THE RESULT OF THE FEMORAL COMPONENT ARTICULATING ON THE POSTERIOR EDGE. THE LOAD APPLIED OVER THE SMALL SURFACE AREA RESULTED IN THE LOSS OF POLYETHYLENE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2006. SUBSEQUENTLY, THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6), 2011. THE TIBIAL BEARING WAS REMOVED AND REPLACED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD ANTERIOR STABILIZED TIBIAL BEARING 12MM X 83MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 249620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R