BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM

    MDR report key: 17265902 · Received July 6, 2023

    Report

    Report Number
    1038671-2023-01558
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 13, 2023
    Report Date
    February 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230492
    PMA / PMN Number
    K123342
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 5709540 200-05-29 - INSET PATELLA 29MM, 5795456 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4, 5921263 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 8 YEARS POST OP INITIAL LEFT TKA, THIS 61 Y/O MALE PATIENT WAS REVISED DUE TO LOOSE METAL IMPLANTS AND POLY WEAR. THE PATIENT PRESENTED IN SURGEON OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA'S. THE PATIENT HAS RECALLED IMPLANTS IN BOTH KNEES. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION BILATERAL TKA POSSIBLE POLY SWAP VS FULL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787659 LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862230492

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male SEE H10