BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE IMPLANTS

    MDR report key: 15254387 · Received August 18, 2022

    Report

    Report Number
    1038671-2022-00942
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    February 22, 2022
    Report Date
    October 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307750
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 02-020-13-0340, TRULIANT FEMORAL COMPONENT. NO DEVICE RETURN ANTICIPATED DUE TO CLINICAL STUDY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDIES, EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A 66 YO MALE, HEIGHT: 73 IN, WHO HAD INITIAL IMPLANT ON THE RIGHT KNEE ON (B)(6) 2019, AND HAD A SPACER PLACED ON (B)(6) 2020, PRESENTED WITH INFLAMMATION TO THE RIGHT KNEE ON (B)(6) 2022. THEY UNDERWENT A REVISION OF THE SPACER ON (B)(6) 2022 AND A KNEE ASPIRATION FOR CULTURE. OUTCOME INDICATES CONTINUING. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460471 TRULIANT KNEE IMPLANTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4, 9MM UNK 10885862307750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10