BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC RBK INSERT SZ 2.5, 9MM

    MDR report key: 19434519 · Received May 31, 2024

    Report

    Report Number
    1038671-2024-01634
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    April 22, 2024
    Report Date
    September 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: INITIAL REPORT SUBMITTED IN ERROR. THIS DEVICE IS NOT AVAILABLE FOR USE IN THE US, AND THEREFORE NOT REPORTABLE TO THE FDA.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 6312520 - 02-010-01-0225 - LGC FEMORAL PS CEM LEFT SZ 2.5 6309402 - 02-012-38-2509 - LOGIC RBK INSERT SZ 2.5, 9MM , 6281223 - 02-012-43-2525 - LGC TIBIA RBKTRAY CEM SZ 2.5F/ 2.5T 6331778 - 200-02-35 - THREE PEG PATELLA 35MM , 6454830 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 6167773 - 201-78-81 - 3 TROCAR, MOD. HEX 2PK , S040467 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED , S040716 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED , S049580 - 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS , 1021420158 - A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 65 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 4 YEARS POST OP. THE PATIENT SUFFERED FROM PATELLA WEAR, TIBIAL INSERT WEAR/PITTING, FEMORAL DELAMINATION. EVERYTHING WAS REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299263 LOGIC RBK INSERT SZ 2.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention SEE H10.