BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM RINGLOC CONSTRAINED LINER 36MM

    MDR report key: 1961430 · Received January 14, 2011

    Report

    Report Number
    1825034-2011-00039
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    K030047
    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, NUMBER 4 STATES, "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 HIP PROCEDURE ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2010, DUE TO DISASSOCIATION OF THE CUP AND LINER. IT WAS ALSO REPORTED THAT THE PATIENT HAS A HAEMATOLOGICAL DISORDER THAT CAUSES BONY DEFORMITIES AND HAS POOR MUSCLE TONE IN THE AFFECTED LEG. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM RINGLOC CONSTRAINED LINER 36MM PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 752370

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R