BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-ALT HIP

    MDR report key: 3863818 · Received June 10, 2014

    Report

    Report Number
    1644408-2014-00352
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K072154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS INSTABILITY AFTER 1.8 YEARS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR 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 MADE AVAILABLE 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 SHOWED THIS IS THE SECOND COMPLAINT FOR THIS LOT. THE ROOT CAUSE FOR THE INSTABILITY WAS REPORTEDLY DUE TO THE STEM SUBSIDING. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE STEM SUBSIDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341058 X-ALT HIP LINER / NON-HOODED - NEUTRAL, MP6 32MM LPH ENCORE MEDICAL, L.P. 587F1012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 400-32-000,LOT 53944648