BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC TIB INSERT SIZE 3, 13MM

    MDR report key: 19973386 · Received August 13, 2024

    Report

    Report Number
    1038671-2024-02812
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    February 27, 2024
    Report Date
    October 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862613400
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 6407565 02-010-66-2002 - METAPHYSEAL FEMORAL CONE, MEDIUM, H42MM. 6524455 02-012-64-1812 - TRU FLUTED STM EXT 18MM X120MM BLAST. 7176847 02-012-66-2000 - METAPHYSEAL TIBIAL CONE, ML32MM. A264225 02-010-06-0230 - TRU CC FEMORAL SIZE 3 LEFT. A318649 02-012-50-3014 - TRU TIB AUG 1/2 RL SZ 3, 10MM. A633085 200-02-38 - THREE PEG PATELLA 38MM. A693416 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T. A872427 02-012-64-1880 - TRU FLUTED STM EXT 18MM X 80MM BLAST. A873212 02-010-06-0531 - TRU POST. AUG. SIZE 3, 5MM. A878523 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM. A878528 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD A PREVIOUS REVISION ON (B)(6) 2024; REASON NOT REPORTED. THE PATIENT FELL AND SPLIT OPEN WOUND AND UNDERWENT AN INCISION AND DRAINAGE WITH POLY SWAP ON (B)(6) 2024. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200992 LOGIC CC TIB INSERT SIZE 3, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862613400

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention SEE H11