BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HXL KNEE

    MDR report key: 6836585 · Received August 31, 2017

    Report

    Report Number
    1644408-2017-00750
    Event Type
    Injury
    Date Received
    August 31, 2017
    Date of Event
    August 2, 2017
    Report Date
    October 24, 2017
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    JWH
    UDI-DI
    00888912120241
    PMA / PMN Number
    K113756
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: MANUFACTURER NARRATIVE: THE REASON FOR THE REVISION SURGERY IS DUE TO THE PATIENT'S KNEE BEING UNSTABLE. THE IN-VIVO LENGTH OF PATIENT SERVICE FOR THE IMPLANT WAS 1.8 YEARS. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THERE ARE NO REPORTED PRE-EXISTING PATIENT HEALTH CONDITIONS. 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, DESIGN CRITERIA AND SPECIFICATIONS IN EFFECT AT THE TIME THE PART WAS MANUFACTURED WERE MET. THE COMPLAINT INVESTIGATION HISTORY WAS REVIEWED AND NO TRENDS OR ON-GOING ISSUES WERE DEEMED TO BE PRESENT OR IN NEED OF REVIEW. THIS EVENT IS DEEMED AS NON-PRODUCT RELATED. THE ROOT CAUSE FOR THIS EVENT WAS THE PATIENT HAD KNEE INSTABILITY. THE SCOPE OF THIS INVESTIGATION IS LIMITED WITHOUT HAVING THE EXPLANTED PARTS AVAILABLE TO DJO SURGICAL FOR EVALUATION. OTHER CONDITIONS RELATING TO THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. INVENTORY CONTAINMENT IS NOT REQUIRED SINCE 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'S KNEE BEING UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616979 HXL KNEE SOMBRERO TRI-PEG PATELLA, 32X8MM, E-PLUS JWH ENCORE MEDICAL L.P. 392-09-704 160N1026 00888912120241

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention