BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR RED/LAT 12.5X145

    MDR report key: 2770363 · Received October 3, 2012

    Report

    Report Number
    0001825034-2012-01802
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER NINE STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULTS OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION OR EXCESSIVE WEIGHT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, ON (B)(6) 2012 PATIENT UNDERWENT A REVISION DUE TO PATIENT FALLING CAUSING FEMORAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERLOC POR RED/LAT 12.5X145 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 551700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R