BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 3.5,10MM

    MDR report key: 18863420 · Received March 8, 2024

    Report

    Report Number
    1038671-2024-00437
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    October 31, 2022
    Report Date
    November 14, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862312617
    PMA / PMN Number
    K171045
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: 02-020-13-0235 - TRULIANT CR CEM FEM CR CEM LEFT SZ 3.5 6545513; 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T 6776176; 02-029-99-1001 - FLUTED HEADLESS PIN 3.0" SQUARE HEAD, PK2 25378; 200-02-32 - THREE PEG PATELLA 32MM 6776450. THESE DEVICES ARE USED FOR TREATMENT AND NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 1 YEAR AND 1 MONTH AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341922 TRULIANT TIB IMP CRC INSERT SZ 3.5,10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862312617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.