BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM

    MDR report key: 15370240 · Received September 7, 2022

    Report

    Report Number
    1038671-2022-01041
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    July 18, 2022
    Report Date
    October 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862306425
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 02-020-13-0235 - TRULIANT CR CEM FEM CR CEM LEFT SZ 3.5 SN: (B)(4), 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T SN: (B)(4), 200-02-35 - THREE PEG PATELLA 35MM SN: (B)(4), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK SN: (B)(4), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK SN: (B)(4), 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK SN: (B)(4).

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION WAS REPORTED TO BE DUE TO DEVICE RECALL, NO OTHER REASON REPORTED.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2019. THE PATIENT HAD A POLY SWAP AND WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION OR MEDICAL HISTORY PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617622 TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM 10885862306425

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention SEE H10.