BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 5, 11MM

    MDR report key: 21200343 · Received January 21, 2025

    Report

    Report Number
    1038671-2025-00324
    Event Type
    Injury
    Date Received
    January 21, 2025
    Date of Event
    January 6, 2025
    Report Date
    July 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174550
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D10. D10: 4206683 02-010-03-0350 - LOGIC CR FEMORAL CEM, RIGHT, SZ 5; 4161487 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. D10: (B)(6), 02-010-03-0350 - LOGIC CR FEMORAL CEM, RIGHT, SZ 5, (B)(6), 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T, (B)(6), 200-02-32 - THREE PEG PATELLA 32MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3, H6. H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF TIBIAL INSERT AND PATELLAR PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE FEMORAL COMPONENT AND THE TIBIAL INSERT, HIGH CONTRACT STRESS DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL WITH THE INSERT BEING PACKAGED FOR OVER FIVE YEARS PRIOR TO IMPLANTATION, OR ANY COMBINATION OF THESE POSSIBILITIES.

    Description of Event or Problem · 0

    PHOTOS PROVIDED SHOW WEAR OF THE POLYETHYLENE INSERT AND PATELLA.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 8 YEARS AND 6 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT REPORTED BACK TO THE SURGEON'S OFFICE WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR RIGHT TOTAL KNEE. THE PATIENT WAS REVISED AND UNDERWENT A TIBIAL POLY IMPLANT SWAP AND PATELLA IMPLANT SWAP. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS PROVIDED SHOW WEAR OF THE POLYETHYLENE INSERT. THE PRODUCT IS NOT RETURNING AS IT WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741771 LOGIC CR TIB INSERT STD, SZ 5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174550

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Hospitalization SEE H11| SEE H11