BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC KNEE COMPONENTS

    MDR report key: 22723220 · Received August 5, 2025

    Report

    Report Number
    1038671-2025-02686
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 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/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSION, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D1, H6 IMPACT CODE AND COMPONENT CODE. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF LOOSENING. THE REPORTED LOOSENING COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED 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.

    Additional Manufacturer Narrative · 0

    D10: 03001018045 (B)(6)- GPS IMPLANT KIT V2 (B)(6) 02-010-03-0315 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5 (B)(6) 02-010-01-0315 - LOGIC FEMORAL PS CEM RIGHT SZ 1.5 (B)(6) 02-012-51-1509 - LOGIC TIB INSERT IMPL CRC, SZ 1.5, 9MM (B)(6) 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6) 200-02-32 - THREE PEG PATELLA 32MM (B)(6) 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS (B)(6) 201-78-81 - 3 TROCAR, MOD. HEX 2PK (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6) 201-78-81 - 3 TROCAR, MOD. HEX 2PK (B)(6) 201-78-81 - 3 TROCAR, MOD. HEX 2PK. (B)(6) 201-78-81 - 3 TROCAR, MOD. HEX 2PK. (B)(6) 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 76 YO FEMALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD OSTEOLYSIS AND LOOSENING. ALL IMPLANTS WERE REMOVED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE WERE NO X-RAYS AVAILABLE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF BY THE HOSPITAL. NO DEVICE IMAGES WERE OBTAINED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555828 OPTETRAK LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention SEE H11.