BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM

    MDR report key: 25116583 · Received May 7, 2026

    Report

    Report Number
    3014833750-2026-00009
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    January 1, 2012
    Report Date
    May 7, 2026
    Manufacturer
    RESTOR3D, INC.
    Product Code
    NPJ
    PMA / PMN Number
    K093513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT HAD A FAILURE OF A BICOMPARTMENTAL KNEE IMPLANT, REQUIRING REVISION. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IT IS NOT PRESENTLY CLEAR 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 A PATIENT HAD A FAILURE OF A BICOMPARTMENTAL KNEE IMPLANT, REQUIRING REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456706 IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM BICOMPARTMENTAL KNEE NPJ RESTOR3D, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention