BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM ILOK ANA PRI FML 75 LT

    MDR report key: 4110826 · Received September 23, 2014

    Report

    Report Number
    0001825034-2014-07814
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    July 29, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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: ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2006. DURING POST-OPERATIVE MONITORING, IT WAS NOTED THE PATIENT EXPERIENCED PAIN, SWELLING, EFFUSION, NOISE AND POLY WEAR. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PAIN, SWELLING AND CLICKING. DURING THE PROCEDURE, IT WAS NOTED THAT THE CEMENT WAS NOT ADHERED TO THE FEMORAL COMPONENT. BONY CYSTS NEAR THE FEMORAL PEGS AND IN THE DISTAL FEMUR WERE ALSO NOTED. THE FEMORAL COMPONENT, TIBIAL BEARING, AND TIBIAL TRAY WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PAIN, SWELLING AND CLICKING. DURING THE PROCEDURE, IT WAS NOTED THE CEMENT WAS NOT ADHERED TO THE FEMORAL COMPONENT AND WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589971 MAXIM ILOK ANA PRI FML 75 LT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 643550

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R