BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL IDENTITY CR

    MDR report key: 25116604 · Received May 7, 2026

    Report

    Report Number
    3014833750-2026-00008
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    June 17, 2025
    Report Date
    May 7, 2026
    Manufacturer
    RESTOR3D, INC.
    Product Code
    JWH
    PMA / PMN Number
    K210809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING TIGHTNESS IN EXTENSION AND LOOSENESS IN FLEXION, SUGGESTING THE TIBIAL IMPLANT HAD EXCESSIVE SLOPE. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IT IS NOT PRESENTLY AVAILABLE WHICH MODEL OR VERSION OF THE DEVICE IS IN SCOPE OF THIS ADVERSE EVENT. ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING TIGHTNESS IN EXTENSION AND LOOSENESS IN FLEXION, SUGGESTING THE TIBIAL IMPLANT HAD EXCESSIVE SLOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399467 ITOTAL IDENTITY CR CRUCIATE RETAINING KNEE REPLACEMENT JWH RESTOR3D, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1