BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 4

    MDR report key: 17623109 · Received August 25, 2023

    Report

    Report Number
    1038671-2023-02048
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    July 27, 2022
    Report Date
    February 11, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001160
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: OPTETRAK LOGIC FIT TIBIAL TRAY (REF 02-012-41-4040, 2200899). OPTETRAK LOGIC PSC TIBIAL INSERT (REF 02-012-35-4013, 2474117). OPTETRAK 3 PEG PATELLA (SN (B)(6)).

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2015 DUE TO SEVERE OSTEOARTHRITIS. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 6 YEARS 9 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT INDICATED LOOSENING WITH CHRONIC FRACTURE OF THE PATELLAR COMPONENT AND FINDINGS SUSPICIOUS FOR LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON NOTED SIGNIFICANT SYNOVITIS WAS ENCOUNTERED. THERE WAS SIGNIFICANT OSTEOLYSIS OF BOTH THE MEDIAL LATERAL FEMORAL CONDYLES. OSTEOLYSIS WAS NOTED OF THE MEDIAL TIBIAL PLATEAU. THE PATELLA WAS FOUND TO HAVE CHRONIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386836 LOGIC FEMORAL PS CEM LEFT SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. UNK 10885862001160

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention SEE H10.