BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 22858564 · Received August 21, 2025

    Report

    Report Number
    0002249697-2025-00895
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 21, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. REVISION WAS DUE TO CHRONIC INFECTION. A TRIATHLON TS KNEE WITH STEMS AND AUGMENTS WAS IMPLANTED AS A 'DYNAMIC SPACER' (I.E. AN ARTICULATING SPACER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973742 UNKNOWN KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention| H