BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM

    MDR report key: 16783912 · Received April 21, 2023

    Report

    Report Number
    1038671-2023-00784
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    March 21, 2023
    Report Date
    March 17, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230362
    PMA / PMN Number
    K123342
    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

    CONCOMITANT MEDICAL PRODUCTS: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 5455309 02-010-03-0325 - LOGIC CR FEMORAL CEM, RIGHT, SZ 2.5 6295408 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T 6560535 200-02-35 - THREE PEG PATELLA 35MM 6560572 200-02-35 - THREE PEG PATELLA 35MM 6799765 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 6743534 201-78-81 - 3 TROCAR, MOD. HEX 2PK S103829 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 5500935 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 12000220006 A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS PERFORMED DUE TO POLYETHYLENE DELAMINATION PER THE EXPERIENCE REPORT. HOWEVER, THE PHOTOGRAPHED DEVICE DOES NOT APPEAR TO SHOW SIGNS OF PROSTHESIS WEAR/DELAMINATION. AN ADDITIONAL CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE IMPLANTED POLYETHYLENE COMPONENT IN THE PACKAGING RECALL. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 734, BEARINGS.

    Additional Manufacturer Narrative · 0

    H10- ADDITIONAL INFORMATION - B5.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 YEARS POST OP THE INITIAL RIGHT TKA, THIS 84 Y/O FEMALE PATIENT WAS REVISED DUE TO THE POLY DELAMINATING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING - DISPOSED. PHOTOS ATTACHED. UNABLE TO OBTAIN X-RAYS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION -"PRIMARY SURGERY: (B)(6) 2021 SERIAL NUMBER: (B)(6) (02-012-51-2509) ¿ RECALL. REVISION SURGERY: (B)(6) 2023 (PROCEDURE: RIGHT KNEE REPLACEMENT + ARTHROTOMY WASHOUT + LINER EXCHANGE). INDICATIONS FOR THE REVISION SURGERY ARE SYNCOPE AND SEPTIC ARTHRITIS, AFTER THE REVISION SURGERY THE PATIENT MUST TAKE ANTIBIOTICS FOR SEVERAL MONTHS. CLINICAL DETAILS: PRESENTED WITH FEVERS, KNEE PAIN, SWELLING, ELEVATED CRP AND WCC. ASPIRATE ON THE WARD HAD A TURBID FLUID AND WCC. REMOVAL OF POLY LINER HAD SOME DELAMINATION POSSIBLE CAUSE OF SYNOVIAL REACTION? PULSATILE BETADINE/SALINE LAVAGE WITH FLUID AS WELL TO MINIMIZE BIOFILM. NEW 2.5 9MM CRC POLY INSERT." THE CAUSE OF THE SUSPECTED SEPTIC ARTHRITIS AS RELATED TO THE DEVICES IS UNKNOWN. THE PATIENT RISK FACTORS INCLUDE AGE AND HAVING A JOINT PROSTHESIS. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447160 LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862230362

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female SEE H10.