BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX ILK ANA RF PS FML 65RT VII

    MDR report key: 4171597 · Received October 14, 2014

    Report

    Report Number
    0001825034-2014-08105
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK993159
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08103 / 08105).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO TIBIAL SUBSIDENCE AND FEMORAL LOOSENING. ALL COMPONENTS WERE REMOVED AND REPLACED WITH AN ORTHOPEDIC SALVAGE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650114 MAX ILK ANA RF PS FML 65RT VII PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 544500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R