BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 24492256 · Received March 2, 2026

    Report

    Report Number
    1038671-2026-00217
    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
    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
    303332 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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