BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM

    MDR report key: 19533489 · Received June 13, 2024

    Report

    Report Number
    1038671-2024-01935
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    March 27, 2023
    Report Date
    October 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173607
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    H11. D10. CONCOMITANTS - PRODUCT INFORMATION: (B)(6)-02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T; (B)(6)-02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5 PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 3 YEARS, 3 MONTHS LATER THE PATIENT WAS REVISED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, POLYETHYLENE WEAR, OSTEOLYSIS, SYNOVITIS, IMPLANT-INTERFACE DEBONDING, GENICULATE ARTERY EMBOLIZATION, PATELLAR LATERAL FACETECTOMY. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780519 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173607

    Patients

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