BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMPOWR KNEE

    MDR report key: 8175359 · Received December 18, 2018

    Report

    Report Number
    1644408-2018-01151
    Event Type
    Death
    Date Received
    December 18, 2018
    Date of Event
    December 5, 2018
    Report Date
    December 18, 2018
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    UDI-DI
    00888912166867
    PMA / PMN Number
    K143242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS REVISION SURGERY WAS DUE TO PAIN. THE PREVIOUS SURGERY AND THE REVISION DETAILED IN THIS INVESTIGATION OCCURRED 1.3 YEARS APART. 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 IMPLANT DEVICE HISTORY RECORDS (DHR) SHOWS THAT THE REPORTED COMPONENT USED IN THE PREVIOUS SURGERY MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NON-CONFORMING MATERIAL REPORTS (NCMRS) ASSOCIATED WITH THE PRODUCT THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE DEVICE WAS WITHIN ITS EXPIRATION DATE AT THE TIME OF USE DURING THE PREVIOUS SURGERY. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICE SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE IN NEED OF REVIEW. THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO PAIN. THERE WERE NO FINDINGS DURING THIS INVESTIGATION THAT INDICATE THAT THE REPORTED DEVICE WAS THE SOURCE OR HAD A DIRECT CONNECTION WITH THE EVENT. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO THE EVENT THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL SUCH AS: DEGENERATIVE BONE DISEASE, PATIENT BONE DETERIORATION, EXCESSIVE RANGE OF MOTION, PATIENT ACTIVITIES OR TRAUMA. INVENTORY CONTAINMENT IS NOT REQUIRED AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Additional Manufacturer Narrative · 0

    THIS MDR WAS CREATED INCORRECTLY IN 2018. THE INITIAL REPORT WAS MARKED "INITIAL" AND "FOLLOW UP". THIS FU2 IS TO STATE THAT THE ORIGINAL SHOULD HAVE BEEN AN "INITIAL, 30 DAY" REPORT.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO ANTERIOR KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491278 EMPOWR KNEE EMPOWR 3D KNEETM INS, 9L 10MM, VE JWH ENCORE MEDICAL, L.P. 069T1012 00888912166867

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention