BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMP HIP

    MDR report key: 3874094 · Received June 16, 2014

    Report

    Report Number
    1644408-2014-00369
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO EXCHANGE A FEMORAL HEAD ON A HIP STEM THAT WAS SHOWING WEAR AFTER APPROXIMATELY 15 TO 20 YEARS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS AND INVESTIGATION HISTORY WAS NOT CONDUCTED SINCE A LOT NUMBER WAS NOT PROVIDED OR COULD BE ESTABLISHED FOR THE ORIGINAL SURGERY. INFORMATION WAS NOT PROVIDED THAT DEFINITIVELY IDENTIFIED THE ROOT CAUSE FOR THE PRODUCT WEAR. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON PERFORMED A SIMPLE EXCHANGE OF THE FEMORAL HEAD DUE TO 15 - 20 YEARS OF WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352565 FMP HIP COCR HEAD 36MM KWA ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention