BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2823614 · Received November 2, 2012

    Report

    Report Number
    1644408-2012-00578
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012 IT WAS REPORTED BY AN AGENT THAT A REVISION SURGERY WAS PERFORMED TO REPLACE THE METAL-ON-METAL ACETABULAR LINER WITH CERAMIC ON POLY COMPONENTS. DURING THE REVISION SURGERY A COMPETITOR'S LINER WAS USED. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. 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 TWO SCRAPPED PARTS FOR THE MODULAR FEMORAL NECK DURING THE LATHE OPERATION FOR VISUAL NON-CONFORMANCES. THERE WERE NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE UNIPOLAR SLEEVE, FEMORAL HEAD, AND METAL-ON-METAL LINER. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THERE HAVE BEEN 14 PRIOR COMPLAINTS AGAINST THE METAL-ON-METAL LINER: FOUR DUE TO GENERAL PAIN. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE REVISION SURGERY CANNOT BE DETERMINED WITH CONFIDENCE BECAUSE THE COMPONENTS WERE NOT RETURNED FOR INSPECTION AND THE GENERAL DESCRIPTION OF THE EVENTS LEADING TO THE NEED FOR A REVISION WAS NOT PROVIDED. TO DATE, THERE HAS BEEN NO EVIDENCE PRESENTED THAT SUGGESTS 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 SURGEON REPLACED THE METAL ON METAL ACETABULAR LINER WITH COMPETITOR PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP METAL-ON-METAL LINER- NEUTRAL, MP7 KWA ENCORE MEDICAL, L.P. 53917037

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 411-00-000, LOT 54064703| 410-35-108, LOT 53995356| 497-34-000, LOT A1000000