BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI KNEE REPLACEMENT

    MDR report key: 23687869 · Received December 1, 2025

    Report

    Report Number
    3004153240-2025-00023
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    August 16, 2018
    Report Date
    October 31, 2025
    Manufacturer
    RESTOR3D, INC
    Product Code
    JWH
    UDI-DI
    M572RUK1011113021
    PMA / PMN Number
    K133256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NEED FOR REVISION WAS IDENTIFIED IN IMAGING, WHICH SHOWS SUBSIDENCE OF THE TIBIAL IMPLANT. THE INFORMATION PROVIDED IS NOT SUFFICIENT TO DETERMINE THE EXACT ROOT CAUSE OF THE IMPLANT FAILURE. A REVISION SURGERY IS PLANNED. THE IMPLANTS TO BE EXPLANTED WIL BE RETRIEVED AND ANALYZED AFTER THE SURGERY, EVALUATING THE POLYMER COMPONENT FOR SIGNS OF WEAR DAMAGE ON THE ARTICULATING SURFACE AND THE LOCKING SURFACE WHERE IT INTERFACES WITH THE METALLIC TIBIAL IMPLANT. FURTHERMORE, THE BONE AND JOINT SPACE WILL BE EVALUATED FOR EVIDENCE OF OSTEOLYSIS.

    Description of Event or Problem · 0

    PATIENT IS HAVING A REVISION PROCEDURE TO ADDRESS TIBIAL COMPONENT LOOSENING AND WEAR ON UNICOMPARTMENTAL KNEE FROM 7 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739051 IUNI KNEE REPLACEMENT UNICOMPARTMENTAL KNEE REPLACEMENT JWH RESTOR3D, INC RUK-101-1113 M572RUK1011113021

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention