BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 16539275 · Received March 14, 2023

    Report

    Report Number
    1038671-2023-00433
    Event Type
    Injury
    Date Received
    March 14, 2023
    Date of Event
    February 13, 2023
    Report Date
    May 24, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174246
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANTS: 02-010-03-0320 - LOGIC CR FEMORAL CEM, RIGHT, SZ 2 3839415; 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T 4799257; 200-02-35 - THREE PEG PATELLA 35MM 4714422; 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 4593083; 201-78-81 - 3 TROCAR, MOD. HEX 2PK 913520; 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 5082989; 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 5082996; 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 4977755. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PRESUMED PROSTHESIS WEAR OF THE TIBIAL INSERT. HOWEVER, IMAGES OF THE REVISED INSERT AND PATELLA COMPONENTS DO NOT SHOW SIGNS OF EXCESSIVE PROSTHESIS WEAR INCONSISTENT WITH BEING IMPLANTED FOR APPROXIMATELY 5.25 YEARS. MALALIGNMENT OF THE COMPONENTS AT THE TIME OF IMPLANTATION AND/OR JOINT INSTABILITY CANNOT BE RULED OUT AS POSSIBLE CONTRIBUTING FACTORS IN THIS CASE BECAUSE NO RADIOGRAPHS WERE PROVIDED AND THE REVISED COMPONENTS WERE NOT RETURNED TO EXACTECH FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO THE POLY HAD DELAMINATED. ALL IMPLANTS WERE REMOVED. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICES ARE RETURNING AS THEY WERE DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037126 LOGIC SEE H10 JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2, 9MM UNK 10885862174246

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention SEE H10