BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM

    MDR report key: 20612627 · Received November 5, 2024

    Report

    Report Number
    1038671-2024-04238
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    October 21, 2024
    Report Date
    January 22, 2025
    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

    REPORT NUMBER: 1038671-2024-04239 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3: DEVICE NOT RETURNED. THE REASON FOR THE REVISION MAY BE THE RESULT OF WEAR OF THE PATELLA AND THIRD BODY WEAR ON THE TIBIAL INSERT. CONTRIBUTIONS OF PATIENT-RELATED ISSUES OR IMPLANT ALIGNMENT TO THE WEAR ON THE PATELLA CANNOT 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: CONCOMITATNTS: A10012 - GPS IMPLANT KIT V2 (B)(6). 02-010-04-0340 - LOGIC CR FEMORAL POR, RIGHT, SZ 4 (B)(6). 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS (B)(6). 201-78-81 - 3 TROCAR, MOD. HEX 2PK (B)(6). 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK (B)(6). 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T (B)(6). 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6). 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 63 YO MALE PATIENT WHO HAD AN INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2021, AND WAS REVISED IN (B)(6) 2022, UNDERWENT A SECOND REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 2 YEARS POST THE (B)(6) 2022 PROCEDURE. EVERYTHING WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT AND WAS REPLACED WITH A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS 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 ANALYSIS. THEY WERE DISCARDED AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. FIRST REVISION REPORTED UNDER MDR# 1038671-2022-01234.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49004 LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862230492

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| H SEE H11