BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD ANTERIOR STABLIZED BEARING 12X63

    MDR report key: 3220922 · Received July 11, 2013

    Report

    Report Number
    0001825034-2013-02635
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK050222
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. 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 THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INFECTION. THE JOINT WAS WASHED OUT AND THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319464 VANGUARD ANTERIOR STABLIZED BEARING 12X63 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 413350

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R