BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 23109952 · Received September 22, 2025

    Report

    Report Number
    1038671-2025-02955
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    August 25, 2025
    Report Date
    December 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTION WAS CORRECTED: B5. THE FOLLOWING SECTION WAS UPDATED: D6B. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3, H6, H11 A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE REVISION REPORTED MAY HAVE BEEN DUE TO OSTEOLYSIS, AS STATED IN THE EXPERIENCE REPORT. HOWEVER, THE REASON FOR THE OSTEOLYSIS CANNOT BE DETERMINED AND THE EVENT COULD NOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. ADDITIONALLY, CONTRIBUTIONS FROM USER OR PATIENT RELATED CONSIDERATIONS COULD NOT BE ASSESSED FROM THE REPORTED INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10: 2991245, 02-010-03-0325 - LOGIC CR FEMORAL CEM, RIGHT, SZ 2.5. 3585534, 02-012-48-2513 - LOGIC TIBIAL INSERT SLOPE +, 2.5, 13 MM. 3814462, 02-010-03-0225 - LOGIC CR FEMORAL CEM, LEFT SZ 2.5. 4069107, 201-78-81 - 3 TROCAR, MOD. HEX 2PK. 4119529, 02-012-48-2509 - LOGIC TIBIAL INSERT SLOPE +, SZ 2.5, 9 MM. 42035-04 203-96-42 - (11-3671) STRYKER SYS 6 90X13/21X1.19. 4303781, 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T. 4321465, 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T. 4483649, 200-02-32 - THREE PEG PATELLA 32MM. 4483720, 200-02-32 - THREE PEG PATELLA 32MM. 4544504, 201-78-81 - 3 TROCAR, MOD. HEX 2PK. 4557736, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 4563335, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 4579942, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 4579943, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B2, D6B. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PRIOR CANCELLATION WAS COMMUNICATED IN ERROR. THE REVISION HAD OCCURRED. IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT SIDE KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY EIGHT YEARS SEVEN MONTHS POST THE INITIAL PROCEDURE. ALL IMPLANTS WERE REMOVED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE AVAILABLE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF BY THE HOSPITAL. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT SIDE KNEE IMPLANTED, WAS SEEN BY HIS PROVIDER AND OSTEOLYSIS WAS INDICATED. A REVISION WAS PLANNED BUT WAS CANCELLED FOR UNKNOWN REASONS. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655376 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11.