BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 6 TRIATH TS PLUS TIB INS X3 POLY 9MM

    MDR report key: 25304281 · Received May 27, 2026

    Report

    Report Number
    0002249697-2026-00454
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 27, 2026
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    UDI-DI
    07613327027389
    PMA / PMN Number
    K242831
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT#; DEVICE NAME; LOT#: 5521-B-600; TRI TS BASEPLATE SIZE 6; SXZ4RA. 5565-S-016; TRI PRESS-FIT STEM 16MM X 100MM; 143113. 5565-S-014; TRI PRESS-FIT STEM 14MM X 100MM; 133694. 5543-A-600; TRI POST AUGMENT SZ6 5MM; UNKNOWN. 5540-A-602; TRIATH FEM DISTAL AUG 5MM - SIZE 6 RIGHT; UNKNOWN. 540-A-602; TRIATH FEM DISTAL AUG 5MM - SIZE 6 RIGHT; UNKNOWN. 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

    THE FOLLOWING INFORMATION WAS PROVIDED: THE IMPLANT WAS PLACED IN 2025 FOR KNEE PROSTHESIS REVISION FOLLOWING A PERIPROSTHETIC INFECTION. ON (B)(6) 2026, A TWO-STAGE REVISION PROCEDURE WAS PERFORMED DUE TO SUSPECTED INFECTION OF THE RIGHT KNEE PROSTHESIS, WITH IMPLANTATION OF A CEMENT SPACER (TWO-STAGE RIGHT TKA REVISION). THE REPORT INVOLVES THE ENTIRE KNEE PROSTHESIS SYSTEM, INCLUDING: 1- FEMORAL COMPONENT, 2- FEMORAL STEM, 3 - TIBIAL COMPONENT, 4 - TIBIAL STEM, 5- TIBIAL INSERT WITH POST, 6¿7 FEMORAL AUGMENTS. IMPLANTATION DATE: THE EXACT DAY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139244 NO 6 TRIATH TS PLUS TIB INS X3 POLY 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER JWH STRYKER ORTHOPAEDICS-MAHWAH Y405HT 07613327027389

    Patients

    Seq Age Sex Outcome Treatment
    1