BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR FEMORAL POR, RIGHT, SZ 3

    MDR report key: 8607517 · Received May 14, 2019

    Report

    Report Number
    1038671-2019-00278
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 15, 2019
    Report Date
    December 10, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K140302
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION NOTED THE REVISION REPORTED WAS LIKELY THE RESULT OF THE FEMORAL COMPONENT AND PATELLA APPEARING AS HOT SPOTS ON THE BONE THAT MAY HAVE BEEN DUE TO AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION. (D11) CONCOMITANT DEVICES: 3 PEG PATELLA, 35MM (CN: (B)(4) ; SN: (B)(6). LOGIC CR TIBIAL INSERT, SLOPE ++, SIZE 3, 11MM (CN: (B)(4) ; SN: (B)(6). SECTION(S): NO INFORMATION PROVIDED: A3, A5, B6, AND B7. THE FOLLOWING SECTION(S) HAVE ADDITIONAL INFO; D4 (UDI NUMBER), D6, D10, G4, G5, G7, H1, H2, H3, H4, H6, AND H7.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, H6 CLINICAL CODE, IMPACT CODE.

    Additional Manufacturer Narrative · 0

    PLEASE DISREGARD ADDITIONAL INFORMATION "THE PATIENT EXPERIENCED A FALL AND INJURED HIS RIGHT KNEE" REPORTED IN B5 IN FOLLOW UP #2, AS IT WAS DETERMINED THAT THE PATIENT'S FALL OCCURRED PRIOR TO THE INITIAL IMPLANTATION. THE REST OF THE ADDITIONAL INFORMATION REPORTED IS ACCURATE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: THE REVISION REPORTED MAY HAVE BEEN DUE TO LOOSENING AND PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. 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

    AS REPORTED, APPROXIMATELY 1 YEAR AND 5 MONTHS POST THE INITIAL TKA, THE PATIENT EXPERIENCED A FALL AND INJURED HIS RIGHT KNEE. THE PATIENT UNDERWENT A BONE SCAN WHICH WAS REPORTED TO SHOW INCREASED UPTAKE IN THE RIGHT PATELLA REGION, THOUGHT TO BE DUE TO POSSIBLE LOOSENING OF THE PATELLA BUTTON, AND HYPERAEMIA AT THE RIGHT TIBIAL TUBERCLE IN KEEPING WITH LIGAMENTOUS INSERTIONAL CHANGE AND UPTAKE WAS OTHERWISE UNREMARKABLE IN RELATION TO THE RIGHT KNEE PROSTHESIS. THE BONE SCAN CONFIRMED THAT THE PATIENT HAS SUBSEQUENTLY DEVELOPED COMPONENT LOOSENING. THE SURGEON RECOMMENDED THAT THE PATIENT UNDERGO A REVISION TOTAL KNEE REPLACEMENT WITH CEMENT FIXATION OF THE DEVICES. THE PATIENT WAS REVISED.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 3 PEG PATELLA, 35MM (CN: 200-02-35; SN: (B)(4)). LOGIC CR TIBIAL INSERT, SLOPE ++, SIZE 3, 11MM (CN: 02-012-49-3011; SN: (B)(4)). 510(K) NUMBER: K123687 & K14030.

    Description of Event or Problem · 1

    FEMUR AND PATELLA HOTSPOT ON BONE, SO THE SURGEON DECIDED TO REVISE TO PS AND CHANGE THE PATELLA. THE FEMUR HAD NO ON-GROWTH. THE PATIENT'S HEALTH WAS STABLE LEAVING THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403007 LOGIC CR FEMORAL POR, RIGHT, SZ 3 LOGIC CR FEMORAL POROUS, RIGHT, SIZE 3 JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Required Intervention| H