BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTRAINED HEAD STD

    MDR report key: 2658475 · Received July 17, 2012

    Report

    Report Number
    0001825034-2012-01068
    Event Type
    Injury
    Date Received
    July 17, 2012
    Date of Event
    June 14, 2012
    Report Date
    June 22, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL REVIEW OF THE MODULAR HEAD FOUND THAT THE DEVICE MET ALL DESIGN SPECIFICATIONS. ROOT CAUSE FOR THE DISLOCATION COULD NOT BE DETERMINED. THIS FOLLOW-UP REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01067-1 / 01068-1).

    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 EVENTS, NUMBER EIGHT STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01067 / 01068).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012, DUE TO DISLOCATION. THE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM CONSTRAINED HEAD STD PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 679830

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R