BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM

    MDR report key: 17682006 · Received September 5, 2023

    Report

    Report Number
    1038671-2023-02145
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    August 14, 2023
    Report Date
    January 12, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230362
    PMA / PMN Number
    K123342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: H3: THE CAUSE OF THE PATIENT¿S PAIN 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

    SECTION H10: (G2) REPORT SOURCE - COMPANY REPRESENTATIVE SHOULD HAVE BEEN CHECKED (G4) DATE RECEIVED BY MANUFACTURER ¿ DATE ON FINAL SUBMISSION SHOULD HAVE BEEN (B)(6) 2023 (G6) TYPE OF REPORT - 30-DAY SHOULD HAVE BEEN CHECKED ALONG WITH FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): (B)(6): 02-010-04-0325 - LOGIC CR FEMORAL POR, RIGHT, SZ 2.5. (B)(6): 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T. (B)(6): 200-02-32 - THREE PEG PATELLA 32MM. (B)(6): 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. (B)(6): 201-78-89 - 3 DRILL BIT, MOD. HEX 2 PACK. (B)(6): 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. (B)(6): 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. (B)(6): A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP INITIAL RIGHT TKA, THIS 67 Y/O FEMALE PATIENT WAS REVISED. PATIENT PRESENTED WITH SWELLING AND REDUCED ROM. DAIR PROCEDURE AND LATERAL FACETECTOMY PERFORMED. LINER WAS EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS & X-RAYS ATTACHED. PRODUCT NOT RETURNING - SENT TO RPH FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122745 LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862230362

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female SEE H10