BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM RINGLOC CONSTRAINED LINER 36MM STANDARD FACE

    MDR report key: 2252133 · Received September 16, 2011

    Report

    Report Number
    1825034-2011-00813
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 24, 2011
    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: "EXCESSIVE ACTIVITY, TRAUMA AND WEIGHT HAVE BEEN IMPLICATED WITH PREMATURE FAILURE OF THE IMPLANT BY LOOSENING, FRACTURE, AND/OR WEAR." THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION HIP ARTHROPLASTY PROCEDURE ON (B)(6), 2011 TO PLACE CONSTRAINED COMPONENTS. PATIENT REPORTEDLY FELL AND A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 DUE TO CONSTRAINED LINER DISASSOCIATION FROM THE ACETABULAR CUP SHELL. THE CONSTRAINED LINER WAS REMOVED AND REPLACED. 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 STANDARD FACE PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 302260

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R