BEUDAMED
    FDA Adverse Event Death Summary report: N

    U2 TOTAL KNEE SYSTEM

    MDR report key: 24837933 · Received April 9, 2026

    Report

    Report Number
    9681642-2026-00004
    Event Type
    Death
    Date Received
    April 9, 2026
    Date of Event
    March 25, 2026
    Manufacturer
    UNITED ORTHOPEDIC CORP.
    Product Code
    JWH
    UDI-DI
    04712602345682
    PMA / PMN Number
    K051640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    1. ALL UNITS FROM THE ASSOCIATED LOT HAVE BEEN DISTRIBUTED AND IMPLANTED: 2103-3230 FEMORAL COMPONENT (B)(4) PCS), 2203-3020 TIBIAL BASEPLATE (B)(4) PCS), 2303-3021 TIBIAL INSERT (B)(4) PCS), AND 2403-1020 PATELLA ONSET (B)(4) PCS). NO SIMILAR COMPLAINTS HAVE BEEN REPORTED ASIDE FROM THIS CASE. THEREFORE, THIS EVENT IS CONSIDERED AN ISOLATED CLINICAL CASE AND NOT RELATED TO PRODUCT QUALITY. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. 2. THE PRODUCT ASSOCIATED WITH THIS CASE: (1) U2 TOTAL KNEE SYSTEM FEMORAL COMPONENT, POSTERIOR STABILIZED, #3, RIGHT (PRODUCT NUMBER: 2103-3230 / LOT NUMBER: 23C066B) (UDI: (B)(4). (2) U2 TOTAL KNEE SYSTEM TIBIAL BASEPLATE, CEMENTED, #2 (PRODUCT NUMBER: 2203-3020 / LOT NUMBER: 22C807B) (UDI: (B)(4). (3) U2 TOTAL KNEE SYSTEM TIBIAL INSERT, POSTERIOR STABILIZED, #2, 9MM THICK (PRODUCT NUMBER: 2303-3021 / LOT NUMBER: 23A304C) (UDI: (B)(4). (4) U2 TOTAL KNEE SYSTEM PATELLA, ON SET, SMALL, 29MM DIA. 8MM THICK (PRODUCT NUMBER: 2403-1020 / LOT NUMBER: 22G107F) (UDI: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2023, A PATIENT WITH RIGHT KNEE DISEASE UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY WITH IMPLANTATION OF A FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, AND PATELLAR COMPONENT. THE PROCEDURE WAS UNEVENTFUL. POSTOPERATIVELY, THE PATIENT DEVELOPED FEVER, CHILLS, AND PROGRESSIVE SHOCK, AND WAS TRANSFERRED TO THE ICU. ON (B)(6) 2023, THE PATIENT EXPERIENCED CARDIAC ARREST TO MULTIPLE ORGAN FAILURE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898750 U2 TOTAL KNEE SYSTEM U2 TOTAL KNEE SYSTEM JWH UNITED ORTHOPEDIC CORP. 23C066B 04712602345682

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death