BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 12MM

    MDR report key: 17259828 · Received July 5, 2023

    Report

    Report Number
    1038671-2023-01535
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    March 13, 2020
    Report Date
    February 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304285
    PMA / PMN Number
    K171045
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10. CONCOMITANTS: 6378819, 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T. 6384284, 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT. 6424810, 02-020-11-0330 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3. S021606, 02-022-35-3013 - TRULIANT TIB IMP PS INSERT SZ 3 13MM. H6. INVESTIGATION RESULTS - THE TRULIANT TIB IMP PS INSERT SZ 3 12MM DEVICE WITH SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT¿S PAIN CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THE PATIENT HAS BILATERAL KNEE REPLACEMENTS. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS SUBMITTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT 1038671-2023-01535.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 AND CLAIMS TO HAVE PAIN, SUFFERING, DIFFICULTY WALKING, AND REQUIREMENT OF FUTURE SURGERIES. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775381 TRULIANT TIB IMP PS INSERT SZ 3 12MM SEE H10 JWH EXACTECH, INC. 02-022-35-3012 10885862304285

    Patients

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