BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 79MM

    MDR report key: 4110795 · Received September 23, 2014

    Report

    Report Number
    0001825034-2014-07829
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 28, 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
    MS, 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: ¿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 A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A SUBSIDED TIBIAL TRAY. THE TIBIAL TRAY AND TIBIAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589911 BIOMET CC CRUCIATE TRAY 79MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 573390

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R