BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRNY II CR LKG FEM IMP BUMPER RT

    MDR report key: 25240475 · Received May 21, 2026

    Report

    Report Number
    1020279-2026-00675
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 21, 2026
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556085233
    PMA / PMN Number
    K121443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A TKA, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT SPLIT IN HALF WHILE IMPACTING THE FEMUR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180324 JRNY II CR LKG FEM IMP BUMPER RT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 13FBG0024 00885556085233

    Patients

    Seq Age Sex Outcome Treatment
    1