BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVEALATION HIP

    MDR report key: 1943558 · Received December 6, 2010

    Report

    Report Number
    1644408-2010-00653
    Event Type
    Other
    Date Received
    December 6, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K973685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - A STRESS FRACTURE WAS CONFIRMED POST FOUR YEARS, BY LOOSENING. THE SURGEON SEES THE LOOSENING WAS APPARENTLY CREATED BY EARLY METAL DEBRIS. BONE IN GROWTH IS NOT FULFILLED WITH THIS DESIGN. THE DEVICE SEEMS TO BE FIXED DISTALLY AND GETS LOOSE PROXIMATELY. BLACK ABRASIVE POWDER WAS OBSERVED OVER THE FEMUR. NO PHYSIOLOGICAL TEST WAS CONDUCTED AS THE OBJECT COULD NOT DEFINITELY BE IDENTIFIED AS TITANIUM ABRASIVE POWDER. THE DOCTOR DIAGNOSED A SIMILAR CASE AS MICRO FRACTURE DUE TO EXCESSIVE CURETTING WHEN THE SURGEON PRESENTED THE SIMILAR CASE DURING THE ROUND TABLE MEETING AT (B)(6), 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEALATION HIP FEMORAL STEM LPH ENCORE MEDICAL, L.P. 545981B

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention 497-28-350, LOT# 243092A| 499-28-006, LOT# 283922