BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-ALT HIP

    MDR report key: 3522676 · Received November 22, 2013

    Report

    Report Number
    1644408-2013-00660
    Event Type
    Injury
    Date Received
    November 22, 2013
    Date of Event
    November 8, 2013
    Report Date
    November 8, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K072154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS PATIENT REQUEST AFTER 2 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 10TH COMPLAINT FOR THIS PRODUCT (3 DISLOCATION, 4 INFECTION, 1 TRAUMA, 1 STABILITY/POOR JOINT, 1 REVISION SURGERY), SECOND FOR THIS LOT. THE ROOT CAUSE FOR THE REVISION COULD NOT BE DETERMINED WITH CONFIDENCE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. HOSPITAL DISPOSED.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE SURGERY REMOVING THE STRYKER REJUVENATE HIP STM AND HEAD PER THE PT'S REQUEST, REPLACING THEM WITH A ZIMMER PRODUCT. HE CHANGED OUT THE DJO HXL/FMP LINER, AND THE ORIGINAL DJO SHELL REMAINED IN PT. THIS WAS A VOLUNTARY REMOVAL, NOT DUE TO A DJO PRODUCT COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610571 X-ALT HIP LINER/NON-HOODED - NEUTRAL, MP8 LPH ENCORE MEDICAL, L.P. 692F1004

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention