BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR TAPERLOC FEMORAL 1.5 X 145 MM

    MDR report key: 2220881 · Received August 23, 2011

    Report

    Report Number
    1825034-2011-00735
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K030055
    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 WARNINGS, IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS". THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2011. SUBSEQUENTLY, THE SURGEON REPORTED MAKING AN ERROR IN STEM CHOICE, LEADING TO A REVISION PROCEDURE ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR TAPERLOC FEMORAL 1.5 X 145 MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 621670

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R