BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 3.5,10MM

    MDR report key: 15454650 · Received September 20, 2022

    Report

    Report Number
    1038671-2022-01140
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    August 30, 2022
    Report Date
    March 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862312617
    PMA / PMN Number
    K181794
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 6657637, 02-020-14-0235 - TRULIANT CR POR FEM CR POR LEFT SZ 3.5, 6667564, 02-022-55-3525 - TRULIANT POR TIB TRAY SIZE 3.5F/2.5T, 6673602, 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT, 5292282, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK.

    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 ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER, IT IS MOST LIKELY RELATED TO PATIENT CONDITIONS. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL LEFT TKA, THIS 37 Y/O MALE PATIENT WAS REVISED DUE TO THE BONE NEVER GREW INTO THE POROUS COMPONENTS. THE POROUS COMPONENTS WERE REVISED TO CEMENTED COMPONENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING, HOSPITAL POLICY. NO OTHER INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL LEFT TKA, THIS 37 Y/O MALE PATIENT WAS REVISED DUE TO THE BONE NEVER GREW INTO THE POROUS COMPONENTS. THE POROUS COMPONENTS WERE REVISED TO CEMENTED COMPONENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING, HOSPITAL POLICY.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL LEFT TKA, THIS 37 Y/O MALE PATIENT WAS REVISED DUE TO THE BONE NEVER GREW INTO THE POROUS COMPONENTS. THE POROUS COMPONENTS WERE REVISED TO CEMENTED COMPONENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING, HOSPITAL POLICY. NO OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2661930 TRULIANT TIB IMP CRC INSERT SZ 3.5,10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-022-51-3510 UNK 10885862312617

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention SEE H10