BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 22320742 · Received June 24, 2025

    Report

    Report Number
    1038671-2025-02369
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 5, 2025
    Report Date
    August 29, 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: (B)(6) A10012 - GPS IMPLANT KIT V2 (B)(6) 203-90-01 - 11-2624 POWERPRO SAWBLADE (B)(6) 02-012-47-1509 - LOGIC TIBIAL INSERT STD, SZ 1.5, 9 MM (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6) 02-010-04-0315 - LOGIC CR FEMORAL POR, RIGHT, SZ 1.5 (B)(6) 200-02-32 - THREE PEG PATELLA 32MM (B)(6) 203-90-21 - (2716) HALL PWR PRO/VERS PWR PLUS 90X13/21X1.19MM (B)(6) 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T (B)(6) 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK (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) 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6, H11. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 4 YEAR 10 MONTHS POST INITIAL OPERATION. THE PATIENT PRESENTED PAIN TO THE SURGEON. SURGEON REMOVED ALL THE COMPONENTS AND REPLACED THEM WITH A COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064892 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization SEE H11