BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 13MM

    MDR report key: 17663270 · Received August 31, 2023

    Report

    Report Number
    1038671-2023-02119
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    August 31, 2021
    Report Date
    January 15, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304292
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 02-020-11-0330 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3 5143660. 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T 5508956. 1510-S - CEMEX SYSTEM FAST 70 GM AB2786. 200-02-35 - THREE PEG PATELLA 35MM 5534067. 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 5258889. 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE 5509153. 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK 3932952. 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK 5512335. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS-THE CAUSE OF THE PATIENT¿S INSTABILITY AND SUBSEQUENT REVISION 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. THERE IS NO MENTION IN THE OPERATIVE REPORT OF DEVICE MALFUNCTION OR WEAR, THE TIBIAL INSERT WAS INCREASED IN SIZE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 3 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2021. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2021: DIAGNOSIS: RIGHT TOTAL KNEE PROSTHETIC INSTABILITY. INSPECTION OF THE FEMORAL AND TIBIAL METAL IMPLANTS WAS DONE AFTER REMOVAL FINDING NO EVIDENCE OF EROSION OR LOOSENING AT ANY POSITION. A 17 MM POLYETHYLENE TRIAL WAS SUBSTITUTED FINDING THE INSTABILITY TO BE COMPLETELY ATTENDED. THE PATIENT AWAKENED AND RETURNED TO THE RECOVERY ROOM WITHOUT COMPLICATIONS.

    Description of Event or Problem · 0

    THE 13MM INSERT WAS REPLACED WITH A 17MM TO ADDRESS THE PATIENT'S KNEE STABILITY. THERE IS NO MENTION OF DEVICE MALFUNCTION OR WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437462 TRULIANT TIB IMP PS INSERT SZ 3 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. UNK 10885862304292

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention