BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINEAR HIP

    MDR report key: 3593339 · Received January 8, 2014

    Report

    Report Number
    1644408-2014-00001
    Event Type
    Other
    Date Received
    January 8, 2014
    Date of Event
    December 30, 2013
    Report Date
    December 30, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE REVISION SURGERY WAS FOR DEVICE LOOSENING. THERE WAS NO INFORMATION ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, MEDICAL CONTRAINDICATIONS, ALLERGIES, OR OTHER FACTORS THAT COULD HAVE CONTRIBUTED TO THE REVISION WAS PROVIDED WITH THIS COMPLAINT. NO X-RAYS OF THE COMPONENTS IN-VIVO WERE PROVIDED FOR REVIEW. 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 SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. (B)(4). A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SEVERAL FACTORS THAT CAN CONTRIBUTE TO THIS EVENT INCLUDE HYPERSENSITIVITY TO METAL, HIGH PATIENT ACTIVITY LEVEL, IMPROPER IMPLANT ALIGNMENT, EXCESSIVE RANGE-OF-MOTION, TRAUMA, OR FOREIGN BODY INTERACTION. THERE IS NO EVIDENCE THAT A MATERIAL, DESIGN, OR DIMENSIONAL PROBLEM CONTRIBUTED TO THIS REVISION SURGERY.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF THIGH PAIN. THE X-RAYS SHOWED LOOSENING OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14511 LINEAR HIP LATERAL OFFSET STEM LPH ENCORE MEDICAL, L.P. 118C1018

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 497-28-350, LOT 634C1059