BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM

    MDR report key: 18937343 · Received March 19, 2024

    Report

    Report Number
    1038671-2024-00570
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    September 13, 2017
    Report Date
    February 3, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230409
    PMA / PMN Number
    K123342
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE PROSTHESIS WEAR REPORTED CANNOT BE CONFIRMED AS THE DEVICES REMAIN IMPLANTED AND NO RELEVANT CLINICAL INFORMATION HAS BEEN PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS - PRODUCT INFORMATION: (B)(6) 02-010-03-0330 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3; (B)(6) 200-02-35 - THREE PEG PATELLA 35MM; (B)(6) 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM; (B)(6) 204-70-00 - TIBIAL STEM EXT. SCREW; (B)(6) 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411939 LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862230409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10