BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 22561291 · Received July 21, 2025

    Report

    Report Number
    1038671-2025-02540
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    February 28, 2025
    Report Date
    September 2, 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

    D10: CONCOMITANTS: 11000017101 (B)(6) - GPS IMPLANT KIT V2 12002017096 (B)(6) - GPS IMPLANT KIT V2 (B)(6) 02-012-48-3511 - LOGIC TIBIAL INSERT SLOPE +, SZ 3.5, 11 MM (B)(6) 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS (B)(6) 02-012-48-3511 - LOGIC TIBIAL INSERT SLOPE +, SZ 3.5, 11 MM (B)(6) 02-010-04-0235 - LOGIC CR FEMORAL POR, LEFT, SZ 3.5 (B)(6) 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK (B)(6) 200-02-35 - THREE PEG PATELLA 35MM (B)(6) 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T (B)(6) 200-02-38 - THREE PEG PATELLA 38MM (B)(6) 02-010-04-0335 - LOGIC CR FEMORAL POR, RIGHT, SZ 3.5 (B)(6) 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T (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. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D1, H6. 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; HOWEVER, MAY HAVE RESULTED FROM INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D6A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, WHO HAD AN INITIAL LEFT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 6 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH PAIN. THE SURGEON BOOKED THE REVISION, REMOVED ALL IMPLANTS AND REPLACED THEM WITH A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF BY THE HOSPITAL. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944315 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