BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR POR FMRL-LT 70

    MDR report key: 2893280 · Received January 2, 2013

    Report

    Report Number
    0001825034-2012-02666
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK033489
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, AN IRRIGATION AND DEBRIDEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2012 ALTHOUGH TESTS FOR INFECTION WERE NEGATIVE. DURING THE I&D PROCEDURE, THE SURGEON NOTED THE FEMORAL COMPONENT WAS LOOSE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH SPACERS. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933 VANGUARD CR POR FMRL-LT 70 PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 991170

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R