BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR TIBIAL BEARING 10X79/83

    MDR report key: 3140807 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01756
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    March 24, 2013
    Report Date
    May 2, 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

    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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED (B)(6) 2013 DUE TO INFECTION. THE TIBIAL BEARING AND LOCKING BAR WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242020 VANGUARD CR TIBIAL BEARING 10X79/83 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 676150

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R