BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNASTY® A-CLASS® STD POLY LINER 28MM GROUP B

    MDR report key: 21790950 · Received April 7, 2025

    Report

    Report Number
    3010536692-2025-00145
    Event Type
    Injury
    Date Received
    April 7, 2025
    Report Date
    August 14, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDI
    PMA / PMN Number
    K140043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALLEGEDLY, THE PROBLEM WITH THE RIGHT HIP IMPLANT, MOST LIKELY, THE ACETABULAR CUP INSERT IS THAT HAS CAUSED SWELLING AND PAIN WITH WEIGHT BEARING SINCE LAST JANUARY 2024. SECOND SURGERY EXPECTED. MPO PRODUCTS RELATED: PRODUCT ID: DBFPGB48 / DYNASTY® BF SHELL PRIMARY / LOT NO. 1944278 / QTY: 1. PRODUCT ID: 111-152-611 / CERAMIC FEMORAL HEAD / LOT. NO. 1393716 / QTY: 1. PRODUCT ID: PHA04404 / FEMORAL HEAD BIOLOX DELTA / LOT NO. 1878056 / QTY: 1. PRODUCT ID: PRTL2S03 / PROFEMUR® TL2 STEM SZ 3 / LOT NO. 1887385 / QTY: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048201 DYNASTY® A-CLASS® STD POLY LINER 28MM GROUP B HIP COMPONENT JDI MICROPORT ORTHOPEDICS INC. DLXPGB28 1967420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention