BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC FEMORAL SIZE 2, RIGHT

    MDR report key: 16527322 · Received March 13, 2023

    Report

    Report Number
    1038671-2023-00413
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    November 3, 2016
    Report Date
    December 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE BONE FRACTURE AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 74 YO WHITE MALE PATIENT EXPERIENCED RIGHT KNEE CHRONIC OSTEOMYELITIS, DUE TO PERIPROSTHETIC FRACTURE. THE PATIENT¿S RIGHT KNEE WAS REVISED. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2017. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 4128178 02-012-65-2017 - LOGIC CC TIB INSERT SIZE 2, 17MM. 4085571 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T. 4113259 02-012-60-1440 - LOGIC STEM EXT 14MM X 40MM. 4112989 02-012-60-1612 - LOGIC STEM EXT 16MM X 120MM. 4158828 200-02-29 - THREE PEG PATELLA 29MM. 4090717 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 74 YO WHITE MALE PATIENT EXPERIENCED RIGHT KNEE CHRONIC OSTEOMYELITIS, DUE TO PERIPROSTHETIC FRACTURE. THE PATIENT¿S RIGHT KNEE WAS REVISED. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2017. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 74 YEAR-OLD WHITE MALE PATIENT EXPERIENCED CHRONIC OSTEOMYELITIS, DUE TO PERIPROSTHETIC FRACTURE. THE REVISION SURGERY OF THE EXACTECH COMPONENT WAS ON (B)(6) 2017. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445670 LOGIC CC FEMORAL SIZE 2, RIGHT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| O