BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY/HEAD MODULAR CALCAR PROXIMAL FEMORAL REPLACEMENT

    MDR report key: 1896798 · Received November 11, 2010

    Report

    Report Number
    1825034-2010-00523
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K031693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA. 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, #9 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 A HIP REVISION PROCEDURE ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS FURTHER REVISED ON (B)(6) 2010, DUE TO FRACTURE OF THE PROXIMAL FEMORAL COMPONENT AND THE LOCKING SCREW OF THE DISTAL BOWED STEM. A DELAY OF MORE THAN HALF AN HOUR OCCURRED AS THE SURGEON PERFORMED AN OSTEOTOMY TO REMOVE THE STEM. THE PROXIMAL FEMORAL COMPONENT WAS ALSO REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLORY/HEAD MODULAR CALCAR PROXIMAL FEMORAL REPLACEMENT PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 875940

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R