BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY SIGMA KNEE

    MDR report key: 8199733 · Received December 26, 2018

    Report

    Report Number
    MW5082627
    Event Type
    Injury
    Date Received
    December 26, 2018
    Date of Event
    December 4, 2013
    Report Date
    December 23, 2018
    Manufacturer
    DEPUY SYNTHES, INC.
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A TOTAL KNEE REPLACEMENT IN (B)(6) 2013 @ (B)(6) HOSPITAL IN (B)(6). PERFORMED BY DR. (B)(6). I AM SINGLE/LIVE ALONE/NO ONE TO CARE OR HELP WITH MY CARE. AFTER 4 DAYS IN THE HOSPITAL, I WAS TRANSFERRED TO A NURSING HOME FOR A 20 DAY STAY WITH THERAPY. IT WAS A TRAUMATIC EXPERIENCE. I NEVER WAS PAIN FREE. BY (B)(6) 2016, I COULD STAND THE PAIN NO LONGER. I WENT TO THE HOSPITAL AND HAD X-RAYS WHICH SHOWED PROBABLE TIBIAL PLATE LOOSENING AND POSSIBLE INFECTION. I HAD A NUCLEAR MEDICINE STUDY PERFORMED WITHIN A MONTH WHICH RULED OUT INFECTION. BECAUSE OF THE MENTAL TRAUMA I SUFFERED AFTER THE REPLACEMENT I CONTINUED TO ENDURE THE PAIN UNTIL (B)(6) 2018 WHEN I HAD A TOTAL KNEE REVISION DONE @ (B)(6) HOSPITAL IN (B)(6). PERFORMED BY DR. (B)(6). HIS OPERATIVE REPORT DOCUMENTED THE LOOSENING OF THE TIBIAL PLATE AND THE FAILURE OF THE CEMENT AND DEBONDING WHICH HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034206 DEPUY SIGMA KNEE PROSTHESIS, KNEE LOD DEPUY SYNTHES, INC.
    1034207 HV CEMENT BONE CEMENT LOD DEPUY SYNTHES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R