BEUDAMED
    FDA Adverse Event Other Summary report: N

    X-ALT HIP

    MDR report key: 3214095 · Received July 3, 2013

    Report

    Report Number
    1644408-2013-00349
    Event Type
    Other
    Date Received
    July 3, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K072154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS PAIN AFTER 9.8 MONTHS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE HOSPITALIZATION - INITIAL OR PROLONGED AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, 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 BY 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 EIGHTH COMPLAINT FOR THIS PRODUCT: FIVE DUE TO INFECTION, ONE DUE TO PAIN, ONE DUE TO TRAUMA, AND ONE OF A DIMENSIONAL CONCERN. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE OF THE PAIN COULD NOT BE DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE IS NO INDICATION OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - THE PT COMPLAINED ABOUT HIP PAIN FOLLOWING A TOTAL HIP ARTHROPLASTY. THE SURGEON TRIED TO REMOVE THE STEM AND REPLACE IT, BUT COULD NOT REMOVE THE STEM. DUE TO THIS HE ONLY REPLACED THE LINER AND HEAD. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303517 X-ALT HIP LINER/NON-HOODED - NUETRAL, MP9 LPH ENCORE MEDICAL, L.P. 701F1005

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 400-03-402, LOT 871B1015