BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC KNEE SYSTEM

    MDR report key: 16542347 · Received March 14, 2023

    Report

    Report Number
    1038671-2023-00440
    Event Type
    Injury
    Date Received
    March 14, 2023
    Date of Event
    February 28, 2022
    Report Date
    September 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 02-012-45-3040 - LGC TIBIAL FIT TRAY CEM SZ 3F / 4T. 02-012-60-1612 - LOGIC STEM EXT 16MM X 120MM. 02-012-60-2012 - LOGIC STEM EXT 20MM X 120MM. 02-010-06-0531 - LOGIC POST. AUG. BLOCK SIZE 3, 5MM. 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM. 02-010-06-0531 - LOGIC POST. AUG. BLOCK SIZE 3, 5MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, D1, D4, D6A, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, F, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE CLINICAL SYMPTOM OF PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED AND THE EVENT CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS 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

    IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 68 YO FEMALE PATIENT NOTED RECENT LEFT KNEE PAIN, RIGHT KNEE SEVERE OA. THE DATE OF ONSET IS UNKNOWN. THE PATIENT UNDERWENT REVISION SURGERY DUE TO ASEPTIC LOOSENING. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037200 LOGIC CC KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other| R