BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON INSERT PS NUM4 14MM

    MDR report key: 23606345 · Received November 20, 2025

    Report

    Report Number
    0002249697-2025-01353
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    August 11, 2025
    Report Date
    November 20, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327390759
    PMA / PMN Number
    K173849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: 5512-F-301; TRI TS FEMUR SZ3 LEFT; (B)(6). 5560-S-209; TRI CEMENTED STEM 9MMX100MM; (B)(6). 5521-B-400; TRI TS BASEPLATE SIZE 4; (B)(6). 5560-S-209; TRI CEMENTED STEM 9MMX100MM; (B)(6). IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. SURGEON REPORTED THE REVISION CONSTRUCT AS A 'DYNAMIC SPACER.' AN ASSOCIATED REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529258 X3 TRIATHLON INSERT PS NUM4 14MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH JW7AH8 07613327390759

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Hospitalization| R