BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM RINGLOC CONSTRAINED LINER 36MM / PLUS 5MM STANDARD FACE SIZE 24

    MDR report key: 1984618 · Received February 11, 2011

    Report

    Report Number
    1825034-2011-00092
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    K030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 POSSIBLE ADVERSE EFFECTS, NUMBER EIGHT STATES,"DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." EVALUATION IN PROCESS, BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT SUBMITTED FEBRUARY 11, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010, AT WHICH TIME A CONSTRAINED ACETABULAR LINER AND CONSTRAINED MODULAR HEAD WERE IMPLANTED. SUBSEQUENTLY, THE PATIENT SUFFERED A FALL AND DISLOCATION RESULTING IN TWO CLOSED REDUCTION PROCEDURES PRIOR TO REVISION SURGERY. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011, DUE TO INSTABILITY. THE CONSTRAINED MODULAR HEAD AND CONSTRAINED ACETABULAR LINER WERE REMOVED AND REPLACED. THE ACETABULAR CUP REMAINS IMPLANTED. 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 / PLUS 5MM STANDARD FACE SIZE 24 PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 147930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R