BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 22959164 · Received September 3, 2025

    Report

    Report Number
    1038671-2025-02874
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 16, 2025
    Report Date
    September 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 4858014 02-010-03-0230 - LOGIC CR FEMORAL CEM, LEFT, SZ 3. 4818404 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T. 4790258 02-012-47-3009 - LOGIC CR TIB INSERT STD, SZ 3, 9MM. 4791165 200-02-32 - THREE PEG PATELLA 32MM. 4082499 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK. 6290782 02-020-13-0330 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3. 5968558 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T. 5994065 02-022-51-3011 - TRULIANT TIB IMP CRC INSERT SZ 3, 11MM. 6036315 200-02-32 - THREE PEG PATELLA 32MM. 6298349 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. S047944 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. S036472 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED A 78 YO FEMALE PATIENT, WHO HAD A LEFT KNEE IMPLANTED UNDERWENT A REVISION PROCEDURE, DATE UNKNOWN. THE PATIENT HAD REOCCURRING INFECTION FOR 3 YEARS. THEIR LEG LENGTH WAS SHORTENED. THE SURGEON REMOVED THE POLY AND CHECKED FIXATION ON THE OTHER IMPLANTS AND DECIDED TO KEEP THEM I AS THEY WERE WELL FIXED. THE 12MM INSERT WAS REPLACED WITH A 15MM INSERT. THERE WERE NO DEVICE BREAKAGES, BUT A SURGICAL DELAY OF LESS THAN 45 MINUTES WITH NO ADVERSE EVENT TO THE PATIENT WAS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS THE HOSPITAL KEPT IT. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734299 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| H