BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM LEFT SZ 5

    MDR report key: 15761173 · Received November 9, 2022

    Report

    Report Number
    1038671-2022-01434
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    October 18, 2022
    Report Date
    April 19, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314475
    PMA / PMN Number
    K170240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 5057695 02-022-35-5012 - TRULIANT TIB IMP PS INSERT SZ 5 12MM, 5428300 02-022-45-5050 - TRULIANT TIB FIT TRAY CEM SZ 5F / 5T, 5243033 200-02-41 - THREE PEG PATELLA 41MM, 5261857 201-78-18 - HOLDING PIN HEADLESS NO RIBS W/30 DEG PT 4 PACK.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THIS EVENT HAS BEEN DETERMINED TO BE A DUPLICATE. PLEASE REFERENCE 1038671-2022-01134 FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL LEFT TKA, THIS 63 Y/O MALE PATIENT WAS REVISED DUE TO AND A LOOSE FEMUR. PATIENT WAS COMPLAINING OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING, HOSPITAL WILL NOT RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2953227 TRULIANT PS CEM FEM PS CEM LEFT SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-020-11-0250 UNK 10885862314475

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention