BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 2.5 11MM

    MDR report key: 15257980 · Received August 19, 2022

    Report

    Report Number
    1038671-2022-00945
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    July 18, 2022
    Report Date
    October 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304186
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 02-020-11-0325 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 2.5, 6792590; 02-022-45-2525 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T, 6531018; 200-02-35 - THREE PEG PATELLA 35MM, 6470897; 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 6790703; 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK, S265617; 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK, S110679. NO DEVICE RETURNING DUE TO HOSPITAL POLICIES. RECALL: Z-2112 THRU 2133-2021.

    Additional Manufacturer Narrative · 0

    H7: Z-0023-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 69 YO FEMALE PATIENT, WHO WAS INITIALLY IMPLANTED ON THE RIGHT KNEE ON (B)(6) 2021, UNDERWENT A POLY SWAP REVISION SURGERY APPROXIMATELY 1 YEAR 1 MONTH POST THE INITIAL IMPLANT PROCEDURE DUE TO INSTABILITY. THEY INCREASED POLY THICKNESS FROM A 11MM PS INSERT TO A 15MM PSC INSERT AND WERE REVISED TO EXACTECH DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DUE TO HOSPITAL POLICIES, NO PRODUCTS ARE AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE. 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
    2789964 TRULIANT TIB IMP PS INSERT SZ 2.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 11MM UNK 10885862304186

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention SEE H10.