BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM

    MDR report key: 15245404 · Received August 17, 2022

    Report

    Report Number
    1038671-2022-00928
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    July 25, 2022
    Report Date
    January 22, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307699
    PMA / PMN Number
    K171045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 02-020-13-0335, 6118379 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5. 02-022-45-3535, 6036478 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T. 200-02-38, 6067876 - THREE PEG PATELLA 38MM. 201-78-15, 5972593 - HOLDING PIN MINI SHARP POINT 4 OK. 521-78-23, S017632 - THREADING PIN SIZE 2.3 COLLARED 2PK. 521-78-32, S005968 - THREADING PIN SIZE 3.0 COLLARLESS 2PK. 521-78-32, S006139 - THREADING PIN SIZE 3.0 COLLARLESS 2PK. 521-78-36, S003456 - THREADING PIN SIZE 5.1 COLLARLESS 2PK.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) 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 AND NONCOMPLIANCE.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT RETURNED TO CLINIC WITH PAIN AND TIGHTNESS. THIS WEEK ON MONDAY THE PATIENT WAS REVISED AGAIN DUE TO PAIN AND TIGHTNESS. SURGEON NOTED NON COMPLIANCE WITH POST OP INSTRUCTIONS. THE INSERT WAS DROPPED FROM 15 TO 12MM AND ROM WAS SIGNIFICANTLY IMPROVED. IMPLANTS NOT AVAILABLE TO RETURN. NO FURTHER INFORMATION AVAILABLE. PATIENT LAST KNOWN TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531684 TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-022-51-3509 UNK 10885862307699

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SEE H10