BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 2931657 · Received January 24, 2013

    Report

    Report Number
    1644408-2013-00035
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K003250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REPLACE THE FAILED FEMORAL COMPONENTS AFTER TEN YEARS OF PATIENT USE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE TENTH COMPLAINT FOR THIS PART NUMBER: FOUR DUE TO DISLOCATION, THREE FOR STABILITY/POOR JOINT ISSUES, ONE PACKAGING DUE TO CONTAMINATION FROM FLOODING, ONE LOOSE DEVICE, AND ONE DUE TO REVISION FOR LEG LENGTH. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE FAILED COMPONENT WAS DETERMINED TO BE DUE TO OSTEOLYSIS. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD FAILED FEMORAL COMPONENTS DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33781 FMP HIP COCR HEAD -3.5 KWA ENCORE MEDICAL, L.P. 842851

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 499-28-006, LOT 845581| 427-01-135, LOT 597121