BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 3.5,12MM

    MDR report key: 16737557 · Received April 13, 2023

    Report

    Report Number
    1038671-2023-00681
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 21, 2023
    Report Date
    April 15, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862312624
    PMA / PMN Number
    K171045
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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; NO DEVICE INFORMATION WAS PROVIDED. THE CAUSE OF THE PATIENT¿S INFECTION 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. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT PRODUCTS: TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5 (CAT# 02-020-13-0335 / SERIAL# (B)(4), TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T (CAT# 02-022-45-3525 / SERIAL# (B)(4), ADVANCED PATELLA 29M 3 PEG IMPLANT (CAT# 200-07-29 / SERIAL# (B)(4), HOLDING PIN MINI SHARP POINT 4 PK (CAT# 201-78-15 / SERIAL# (B)(4), THREADED PIN SIZE 3.0 COLLARLESS 2PK (CAT# 521-78-32 / SERIAL# (B)(4), THREADED PIN SIZE 3.0 COLLARLESS 2PK (CAT# 521-78-32 / SERIAL# (B)(4). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL RIGHT TKA, THE FEMALE PATIENT RECENTLY DEVELOPED AN INFECTION. PATIENT HAD I&D WITH POLY EXCHANGE BY SURGEON ON (B)(6) 2023. POLY WAS IN GOOD SHAPE WITH NO SIGNS OF WEAR. NO ISSUES WITH SURGERY. EXPLANT NOT AVAILABLE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250851 TRULIANT TIB IMP CRC INSERT SZ 3.5,12MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3.5,12MM UNK 10885862312624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention