BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPICCI II KNEE MODULAR TIBIA PLATE STANDARD

    MDR report key: 1894475 · Received November 9, 2010

    Report

    Report Number
    1825034-2010-00505
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRY
    PMA / PMN Number
    K971938
    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. 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, #2 STATES "EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION". REVIEW OF STERILIZATION CERTIFICATION INDICATES DEVICES WERE STERILIZED IN ACCORDANCE WITH BIOMET PROCEDURES. THIS REPORT SUBMITTED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT'S LEFT KNEE WAS REVISED TO A TOTAL KNEE ON (B)(6) 2010, DUE TO INFECTION. THE FEMORAL, TIBIAL, AND TIBIAL BEARING COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPICCI II KNEE MODULAR TIBIA PLATE STANDARD PROSTHESIS, KNEE HRY BIOMET ORTHOPEDICS N/A 488090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R