BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/H MODULAR CALCAR DISTAL BOWED STEM

    MDR report key: 1896043 · Received November 10, 2010

    Report

    Report Number
    1825034-2010-00508
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    July 15, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K031693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    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 EVENTS, NUMBER NINE STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." THIS REPORT SUBMITTED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2010, DUE TO FRACTURE OF THE PROXIMAL FEMORAL COMPONENT AND THE LOCKING SCREW OF THE DISTAL BOWED STEM. THE SURGEON SUSPECTS THAT THERE WAS NOT SUFFICIENT BONE SUPPORT TO THE IMPLANT IN THE PROXIMAL FEMUR, WHICH MAY HAVE CONTRIBUTED TO THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M/H MODULAR CALCAR DISTAL BOWED STEM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 509630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R