BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM

    MDR report key: 21845537 · Received April 15, 2025

    Report

    Report Number
    1038671-2025-01827
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    February 27, 2025
    Report Date
    April 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6) 02-010-04-0340 - LOGIC CR FEMORAL POR, RIGHT, SZ 4. (B)(6) 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T. (B)(6) 200-02-38 - THREE PEG PATELLA. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D1, H6. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR. 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, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION 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

    IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2016, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 9 YEARS POST THE INITIAL PROCEDURE. HE PRESENTED TO THE SURGEON WITH PAIN IN THE KNEE. A BONE SCAN SHOWED LOW LEVEL HEAT ON BOTH KNEES. THE SURGEON REMOVED ALL DEVICES. THE POLY TIBIAL INSERTS AND PATELLA WERE BOTH SHOWING EVIDENCE OF WEAR AND MILD OSTEOLYSIS. THERE WAS NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISPOSED OF BY THE HOSPITAL. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350881 LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11