BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 1, 11MM

    MDR report key: 24492311 · Received March 2, 2026

    Report

    Report Number
    1038671-2026-00218
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174147
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-010-03-0310 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1: (B)(6), 02-012-45-1010 - LGC TIBIAL FIT TRAY CEM SZ 1F / 1T: (B)(6), 200-02-32 - THREE PEG PATELLA 32MM: (B)(6), 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM: (B)(6), 204-70-00 - TIBIAL STEM EXT. SCREW: (B)(6). 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 FEMALE PATIENT, WHO HAD A RIGHT TKA, REPORTED EXPERIENCING INTERMITTENT KNEE PAIN, AND NOW IS IN CONSTANT PAIN. SHE WAS SEEN BY HER PCP. SHE NOTED THAT SHE BELIEVED IT WAS A RECALLED POLY IMPLANT. SHE WAS SEEN BY A SURGEON, AND AN X-RAY WAS TAKEN. WEAR AND LOOSENING WERE SEEN. THE PATIENT INDICATED THAT THERE IS PAIN, INSTABILITY, AND LOSS OF MOBILITY. THE SURGEON PRESCRIBED CELECOXIB, AND SHE HAS BEEN SCHEDULED FOR A FUTURE SURGERY. SHE IS CURRENTLY AT HOME WAITING FOR THE SCHEDULED REVISION SURGERY AND REQUIRES THE USE OF A WALKER BECAUSE SHE CAN BARELY WALK. SHE STATED THE X-RAY OF HER KNEE LOOKS LIKE IT IS LEANING TO THE SIDE. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553530 LOGIC CR TIB INSERT STD, SZ 1, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174147

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention SEE H11