BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 20750554 · Received November 21, 2024

    Report

    Report Number
    1038671-2024-04469
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    November 11, 2024
    Report Date
    February 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. CONCOMITANTS: 02-010-04-0335 FEMORAL COMPONENT CR, POROUS SIZE 3.5 (B)(6). 02-012-45-3535 FIT TIBIAL TRAY CEMENTED SIZE 3.5F/3.5T (B)(6). 02-012-48-3509 TIBIAL INSERT CR, SIZE 3.5, 9MM SLOPE + (B)(6). 200-02-38 THREE PEG PATELLA, 38MM (B)(6).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS SUBMITTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT # 1038671-2024-04439.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 8 YEARS AND 8 MONTHS POST INITIAL RIGHT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT PRESENTED WITH PAIN AND SWELLING. A REVISION WAS PERFORMED AND EVERYTHING WAS REMOVED. THE SURGEON ADVISED THAT THERE WAS A LOT OF FLUID REMOVED DURING SURGERY. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235970 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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