BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE TIBIAL TRAY SIGMA

    MDR report key: 11922764 · Received June 2, 2021

    Report

    Report Number
    1818910-2021-11665
    Event Type
    Injury
    Date Received
    June 2, 2021
    Report Date
    May 20, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: PRODUCT/LOT INFORMATION NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # :(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE TITLED, "TEN YEAR OUTCOMES FOR THE PROSPECTIVE RANDOMIZED TRIAL COMPARING UNLINKED, MODULAR BICOMPARTMENTAL KNEE ARTHROPLASTY AND TOTAL KNEE ARTHROPLASTY" WRITTEN BY JEREMY KENG MENG GOH, JERRY YONGQIANG CHEN, NICHOLAS ENG MENG YEO, MING HAN LINCOLN LIOW, AND SHI-LU CHIA, AND SENG JIN YEO PUBLISHED BY THE KNEE AND ACCEPTED BY PUBLISHER 12 AUGUST 2020 WAS REVIEWED. HTTPS://DOI.ORG/10.1016/J.KNEE.2020.08.013 THE ARTICLE'S PURPOSE WAS TO COMPARE BICOMPARTMENTAL KNEE ARTHROPLASTY (BCA) AND TOTAL KNEE ARTHROPLASTY (TKA) FOR SUPERIOR LONG-TERM OUTCOME SCORES. PATIENTS WERE RECRUITED AT THE CLINIC BETWEEN OCTOBER 2007 AND 2009 AND TOTALED 121 PATIENTS WITH 32 EXCLUDED NOT MEETING STUDY CRITERIA AND 41 DECLINING TO PARTICIPATE. RESULTS WERE COMPILED FROM 26 BCA'S AND 22 TKA'S WITH FOLLOW UP OF 10 YEARS WITH AGE RANGING 21 TO 80 YEARS OLD. FIVE HAD PASSED AWAY (UNRELATED) AND FOUR WERE LOST TO FOLLOW UP AT 10 YEARS POST SURGERY. BCA GROUP RECEIVED DEPUY SIGMA HIGH PERFORMANCE PARTIAL KNEE USING UKA AND PATELLOFEMORAL ARTHROPLASTY. TKA GROUP RECEIVED DEPUY SIGMA FIXED BEARING KNEE SYSTEM INCLUDING PATELLA RESURFACING TO ENSURE AN EQUAL COMPARISON OF BKA AND TKA. CEMENT MANUFACTURER IS NOT DISCUSSED. ONLY BCA GROUP EXPERIENCED ADVERSE EVENTS AND ARE CAPTURED IN THIS COMPLAINT. THOSE IN THE BCA GROUP WERE FOUND TO HAVE GOOD OUTCOMES AT 10 YEARS POST ANY REQUIRED INTERVENTIONS TO TREAT ADVERSE EVENTS. NO ADVERSE EVENTS NOTED IN TKA GROUP AND HAD GOOD OUTCOMES AT 10 YEARS. FIGURES 2 AND 3 PROVIDE RADIOGRAPHIC DEPICTION OF BCA WITH NO ADVERSE EVENTS NOTED IN CAPTION DESCRIPTIONS. FIGURES 4 AND 5 PROVIDE RADIOGRAPHIC DEPICTION OF TKA WITH NO ADVERSE EVENTS NOTED IN CAPTION DESCRIPTIONS. DEPUY PRODUCTS (BCA GROUP - SIGMA HIGH PERFORMANCE PARTIAL KNEE): FEMORAL, INSERT, TRAY, PATELLA ADVERSE EVENTS IN BCA GROUP: FOUR PATIENTS WITH PAINLESS LATERAL SUBLUXATION OF PATELLA IN EXTENSION - THREE RECOVERED SPONTANEOUSLY AND ONE REQUIRED ARTHROSCOPIC LATERAL RELEASE ONE PATIENT SUSTAINED POST-TRAUMATIC MEDIAL TIBIAL PLATEAU PERI-PROSTHETIC FRACTURE AT ONE YEAR POSTOP AND TREATED WITH REVISION TO A TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820650 UNK KNEE TIBIAL TRAY SIGMA KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention