BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 5, 11MM

    MDR report key: 19260072 · Received May 7, 2024

    Report

    Report Number
    1038671-2024-01088
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 10, 2024
    Report Date
    August 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174550
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS 4009297 - 02-010-04-0350 - LOGIC CR FEMORAL POR, RIGHT, SZ 5 4904073 - 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T UNASSIGNED - 200-00-00 - KNEE ITEM-MISC 5307224 - 200-02-38 - THREE PEG PATELLA 38MM 5132334 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 5340585 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 5340591 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 5082672 - 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 12001017079 - A10012 - GPS IMPLANT KIT V2 ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, INSTABILITY, OR ANY COMBINATION OF THESE, WHICH LED TO PROSTHESIS WEAR. HOWEVER, THIS COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, THE 56 YEAR OLD MALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO A FAILED LOGIC POLY INSERT. 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. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED AT HOSPITAL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621489 LOGIC CR TIB INSERT STD, SZ 5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 5, 11MM UNK 10885862174550

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention