BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPICCI II KNEE MODULAR TIBIA PLATE X-LARGE LM/RL

    MDR report key: 1884320 · Received October 27, 2010

    Report

    Report Number
    1825034-2010-00477
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 30, 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: LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, AND/OR EXCESSIVE ACTIVITY.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 DUE TO LOOSENING OF THE TIBIAL PLATE. THE TIBIAL PLATE WAS REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPICCI II KNEE MODULAR TIBIA PLATE X-LARGE LM/RL PROSTHESIS, KNEE HRY BIOMET ORTHOPEDICS N/A 402570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R