BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 18440112 · Received January 3, 2024

    Report

    Report Number
    1038671-2024-00012
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    December 7, 2023
    Report Date
    April 15, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174543
    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

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITANTS: 201-78-81 - 3 TROCAR, MOD. HEX 2PK: 4943840; 200-02-41 - THREE PEG PATELLA 41MM: 3707608; 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T: 3970043; 02-010-04-0350 - LOGIC CR FEMORAL POR, RIGHT, SZ 5: 4046480; 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS: 4615294; 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK: 4838196; 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 4973184; 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 4973213. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS, AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR, OSTEOLYSIS, AND FEMORAL LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED A 74 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 6 YEARS 1 MONTH POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO PATELLA WEAR AND DELAMINATION. THE FEMUR COMPONENT WAS REVISED TO A SIZE 5 FEMORAL COMPONENT AND THE TIBIAL INSERT WAS REVISED TO A SZ 5, 9MM TIBIAL INSERT. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO THE CUSTOMER DISCARDED THEM. PHOTOS OF THE EXPLANTS WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435459 LOGIC SEE H10 JWH EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 5, 9MM UNK 10885862174543

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention SEE H10