BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 11MM

    MDR report key: 20571384 · Received October 30, 2024

    Report

    Report Number
    1038671-2024-04193
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    September 25, 2024
    Report Date
    January 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001818
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2024-04192 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B2, D1, H3, H6. THE REASON FOR THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF PATELLAR LOOSENING, PATELLAR AND/OR TIBIAL INSERT WEAR, OR MAY HAVE BEEN SECONDARY TO INCLUSION OF THE PATELLAR COMPONENT IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR AND LOOSENING COULD NOT BE CONFIRMED FROM THE INFORMATION PROVIDED AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 234-03-03 OPTETRAK ASY. FEMORAL PS, CEM, SIZE 3, RIGHT 2618602. 204-04-32 OPTETRAK TIBIAL TRAY TRAP. CEM. SZ 3F/2T 2120526.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 78 YO FEMALE PATIENT WHO HAD AN INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2013 AND WAS REVISED IN (B)(6) 2022, UNDERWENT A SECOND REVISION IN (B)(6) 2024, APPROXIMATELY 2 YEARS 3 MONTHS POST THE (B)(6) 2022 REVISION. POLY EXCHANGE DUE TO THE PATELLA WAS LOOSE AND WORN. INSERT WAS SHOWING SIGNS OF WEAR. THE PATELLA AND INSERT WERE REPLACED WITH A COMPETITOR¿S DEVICES. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896624 LOGIC TIBIA PS MOD INSRT SZ 3 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001818

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| H SEE H11.