BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-ALT HIP

    MDR report key: 9197682 · Received October 16, 2019

    Report

    Report Number
    1644408-2019-01004
    Event Type
    Injury
    Date Received
    October 16, 2019
    Date of Event
    September 18, 2019
    Report Date
    October 16, 2019
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    OQH
    UDI-DI
    00888912100335
    PMA / PMN Number
    K130365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS LOOSENING. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 1 DAY APART. INITIAL OR PROLONGED HOSPITALIZATION IS REQUIRED. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICES WERE DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOW THAT THE REPORTED COMPONENTS USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NON-CONFORMING MATERIAL REPORTS (NCMR) ASSOCIATED WITH THE PRODUCTS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICES WERE VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WERE WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICES SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW. THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY LOOSENING. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THE REPORTED DEVICES WERE DEFECTIVE. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE EVENT. DUE TO SHORT TIME BETWEEN THE PREVIOUS AND REVISION SURGERY IT SEEMS THAT THE EVENT MAY BE OCCURRED DUE TO IMPROPER SURGICAL TECHNIQUES, PATIENT NONCOMPLIANCE WITH MEDICAL INSTRUCTION OR LACK OF POST-OPERATIVE CARE. 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 LOOSE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993423 X-ALT HIP LINER 10 DEG HOODED-NEU, MP9, HXE-PLUS, 40MM OQH ENCORE MEDICAL L.P. 932-40-756 815N2010 00888912100335

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 400-03-402 LOT 871B1178