BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ AA LM PMA

    MDR report key: 3120834 · Received May 20, 2013

    Report

    Report Number
    0001825034-2013-01581
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    February 4, 2011
    Report Date
    January 12, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 10 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT A LEFT MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011 DUE TO ASEPTIC LOOSENING OF THE TIBIAL TRAY. ALL PRODUCTS WERE REMOVED AND PATIENT WAS REVISED TO A TOTAL KNEE. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PCL TO BE INCOMPETENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT A LEFT MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011 DUE TO ASEPTIC LOOSENING OF THE TIBIAL TRAY. ALL PRODUCTS WERE REMOVED AND PATIENT WAS REVISED TO A TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221592 OXF UNI TIB TRAY SZ AA LM PMA PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A 1709659

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R