BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA HIP

    MDR report key: 6004290 · Received October 6, 2016

    Report

    Report Number
    1644408-2016-00741
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 9, 2016
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LZO
    UDI-DI
    00888912023306
    PMA / PMN Number
    K082844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP WITH THE REPRESENTATIVE/AGENT REVEALED THE REASON FOR THIS REVISION SURGERY WAS A DISLOCATION. THE IN-VIVO LENGTH OF SERVICE FOR THE PATIENT'S IMPLANT WAS 2.5 YEARS. 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 DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) REVEALED NO DISCREPANCIES OR ISSUES WITH THE MANUFACTURING OF THIS PART. ALL CRITICAL DIMENSIONS AND SPECIFICATIONS IN EFFECT AT THE TIME THE PART WAS MANUFACTURED WERE MET. THE PRODUCT COMPLAINT REPORT HISTORY WAS REVIEWED AND NO TRENDS OR ON-GOING ISSUES WERE DEEMED AS PRESENT OR IN NEED OF REVIEW. THIS EVENT IS DEEMED TO BE NON-PRODUCT RELATED. THE ROOT CAUSE FOR THE DISLOCATION WAS REPORTED AS A FALL. INVENTORY CONTAINMENT IS NOT REQUIRED AS 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 PATIENT HAVING A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656383 DELTA HIP HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM NEUTRAL LZO ENCORE MEDICAL, L.P. 871B1018 00888912023306

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 931-40-256,LOT 701F1059