BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPICCI FEMORAL

    MDR report key: 1903926 · Received November 20, 2010

    Report

    Report Number
    1825034-2010-00611
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Product Code
    HRY
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. THE DEVICE INFORMATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT SUBMITTED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY IN 2003. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2010, DUE TO SPREAD OF DISEASE. THE FEMORAL COMPONENT AND TIBIAL BEARING WERE REMOVED AND REPLACED TO A TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPICCI FEMORAL PROSTHESIS, KNEE HRY BIOMET SPORTS MEDICINE, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R