BEUDAMED
    FDA Adverse Event Other Summary report: N

    X-ALT HIP

    MDR report key: 3254188 · Received July 25, 2013

    Report

    Report Number
    1644408-2013-00392
    Event Type
    Other
    Date Received
    July 25, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K072154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO ADDRESS A TUMOR IN THE HEAD AND LINER AREA THAT THE PATIENT DEVELOPED AFTER 1.66 YEARS IN-VIVO. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SERIOUS RISK TO THE PATIENT. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR A REVISION. 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 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 FOURTH COMPLAINT FOR THIS PRODUCT: ONE FOR FIXATION, ONE FOR A MIXED PRODUCT LABEL, ONE REVISION, AND ONE WAS INDETERMINATE. THE ROOT CAUSE OF THE REVISION SURGERY WAS MOST LIKELY ATTRIBUTED TO THE PATIENT DEVELOPING A TUMOR IN THE HEAD AND LINER AREA. 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 - DUE TO THE PT HAVING A TUMOR AT THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348313 X-ALT HIP LINER/10 DEGREE HOODED - NEUTRAL, MP6 LPH ENCORE MEDICAL, L.P. 53919669

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention