BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 4, 9MM

    MDR report key: 21792653 · Received April 7, 2025

    Report

    Report Number
    1038671-2025-01756
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    March 21, 2025
    Report Date
    May 1, 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D1 AND H6. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND 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.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 5737968 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; 6238123 02-010-04-0340 - LOGIC CR FEMORAL POR, RIGHT, SZ 4. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 79 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2021, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 3 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE INSERT HAD STARTED TO SHOW EARLY OXIDATION AND INFLAMMATORY RESPONSE. THE LINER WAS EXCHANGED, AND THE PATELLA WAS SURFACED. THE FEMUR AND TIBIA WERE WELL FIXED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISPOSED OF BY THE CUSTOMER. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605666 LOGIC CR TIB INSERT STD, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention SEE H11.