BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGRD ANT STBLZD BRG 12X63.5

    MDR report key: 2810284 · Received October 31, 2012

    Report

    Report Number
    0001825034-2012-02285
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 5, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK050222
    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. INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2012 DUE TO PAIN EXPERIENCED AFTER PATIENT SUFFERED A FALL. ALL IMPLANTS REMOVED AND REPLACED WITH SSK COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGRD ANT STBLZD BRG 12X63.5 PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 857380

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R