BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 3528143 · Received December 12, 2013

    Report

    Report Number
    1644408-2013-00686
    Event Type
    Other
    Date Received
    December 12, 2013
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K003250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE REVISION SURGERY WAS FOR ELEVATED METAL LEVELS AND PAIN. NO INFORMATION ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, MEDICAL CONTRAINDICATIONS, ALLERGIES, 3RD BODY WEAR OR OTHER FACTORS THAT COULD HAVE CONTRIBUTED TO REVISION WAS PROVIDED WITH THIS COMPLAINT. NO X-RAYS OF THE COMPONENTS IN-VIVO WERE PROVIDED FOR REVIEW. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE HOSPITAL KEPT THE DEVICE, SO IT WAS NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. (B)(4). A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE. SEVERAL FACTORS THAT CAN CONTRIBUTE TO THIS EVENT INCLUDE HYPERSENSITIVITY TO METAL, INCREASED METAL WEAR DUE TO HIGH PATIENT ACTIVITY LEVEL, MALPOSITION OF COMPONENTS, TRAUMA OR EXCESSIVE RANGE-OF-MOTION. THERE IS NO EVIDENCE THAT A MATERIAL, DESIGN, OR DIMENSIONAL PROBLEM CONTRIBUTED TO THE REVISION SURGERY.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO METAL LEVELS BEING ELEVATED AND PAIN. THE WAS NO WEAR APPARENT IN THE LINER/HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651556 FOUNDATION HIP METAL-ON-METAL LINER - NEUTRAL, MP5 KWA ENCORE MEDICAL, L.P. 692511

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 497-28-000