BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2.5, 11MM

    MDR report key: 17451514 · Received August 3, 2023

    Report

    Report Number
    1038671-2023-01855
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    April 25, 2023
    Report Date
    December 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159151
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 02-010-03-0325 - LOGIC CR FEMORAL CEM, RIGHT, SZ 2.5, 2130414. 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T, 2772888. 200-03-32 - ONE PEG PATELLA 32MM, 2150668.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR 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 IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2013. THEY UNDERWENT RIGHT KNEE REVISION SURGERY (B)(6) 2023, APPROXIMATELY 9 YEARS 8 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2023, OP REPORT SURGICAL FINDINGS: SIGNIFICANT SYNOVIAL FLUID WITH HYPERTROPHIC SYNOVIAL TISSUE AND GRANULOMATOUS SYNOVIUM LARGE AMOUNT AWARE OF THE MEDIAL TIBIAL INSERT AND MILD PATELLA POLYETHYLENE WEAR. POLYETHYLENE INSERT WAS NOTED TO HAVE SIGNIFICANT WEAR OF THE MEDIAL PLATEAU. NONE OF THE IMPLANTS SHOWED EVIDENCE OF SEVERE BONE LOSS OR LOOSENING. THE PATIENT TOLERATED THE PROCEDURE WELL WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508301 LOGIC CR TIB INSERT STD, SZ 2.5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. UNK 10885862159151

    Patients

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