BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM

    MDR report key: 16088246 · Received January 3, 2023

    Report

    Report Number
    1038671-2023-01651
    Event Type
    Injury
    Date Received
    January 3, 2023
    Date of Event
    December 6, 2022
    Report Date
    February 10, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230492
    PMA / PMN Number
    K123342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 3965226, 02-010-03-0240 - LOGIC CR FEMORAL CEM, LEFT, SZ 4, 4369970, 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T, 2899029, 02-012-47-4011 - LOGIC CR TIB INSERT STD, SZ 4, 11MM, 4243255, 200-02-38 - THREE PEG PATELLA 38MM, 4543407, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 4432174, 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 4544512, 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 4544514, 201-78-81 - 3 TROCAR, MOD. HEX 2PK, 4030513, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, 4090865, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, 4090867, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED, 3009016002, A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED MAY HAVE BEEN DUE TO THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, AND/OR MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, WHICH LED TO PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICES OR PRE-REVISION RADIOGRAPHS WERE NOT PROVIDED WITH THE COMPLAINT SUBMISSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS MALE PATIENT'S KNEE WAS REVISED APPROXIMATELY 1 YEAR POST OP DUE TO POLY WEAR, ALL IMPLANTS REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653499 LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-51-4011 UNK 10885862230492

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention