BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC KNEE COMPONENTS

    MDR report key: 21367650 · Received February 12, 2025

    Report

    Report Number
    1038671-2025-00872
    Event Type
    Injury
    Date Received
    February 12, 2025
    Report Date
    April 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: G3 (PREVIOUS INITIAL REPORT DATE SHOULD BE CORRECTED TO 1/25/2025), H6- HEALTH IMPACT CODE. 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: (IT IS UNKNOWN WHICH COMPONENTS ARE RIGHT OR LEFT) 2349551 02-012-45-3525 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T 2610215 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5 2820573 02-012-35-3509 - LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM 2859364 204-70-00 - TIBIAL STEM EXT. SCREW 2886434 02-012-35-3509 - LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM 2927197 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM 2927225 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM 2966384 02-012-45-3525 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T 2977664 200-02-32 - THREE PEG PATELLA 32MM 2977976 200-02-32 - THREE PEG PATELLA 32MM 2981092 204-70-00 - TIBIAL STEM EXT. SCREW THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT STATED THEY HAD DOUBLE KNEE SURGERY APPROXIMATELY 130 MONTHS AGO AND IS CURRENTLY EXPERIENCING PAIN IN THEIR LEFT KNEE. INFORMATION PROVIDED INDICATES THE PATIENT IS SCHEDULED FOR REVISION SURGERY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163971 OPTETRAK LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11