BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 16MM

    MDR report key: 3921642 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06074
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WARNINGS IT STATES: "THE PATIENT IS TO BE ADVISED OF THE LIMITATIONS OF THE RECONSTRUCTION, AND THE NEED FOR PROTECTION OF THE IMPLANTS FROM FULL LOAD BEARING UNTIL ADEQUATE FIXATION AND HEALING HAVE OCCURRED."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014 WITH AN ORTHOPEDIC SALVAGE SYSTEM. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO LACK OF BONY INGROWTH AFTER A PATIENT FALL. ALL COMPONENTS BESIDES THE TIBIAL PLATE WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399944 OSS TIBIAL POLY BEARING 16MM PROSTHESIS, KNEE JDI BIOMET ORTHOPEDICS N/A 937930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R