BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 3

    MDR report key: 18611539 · Received January 30, 2024

    Report

    Report Number
    1038671-2024-00140
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    August 1, 2023
    Report Date
    September 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001146
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION: (D10) CONCOMITANT DEVICE(S): 2292671 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3. 1913754 02-012-35-3009 - LOGIC TIBIA PS MOD INSRT SZ 3 9MM. 2212610 02-012-44-3011 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM. 2115059 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T. 2293130 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T. 2251151 200-02-35 - THREE PEG PATELLA 35MM. 2332014 200-02-35 - THREE PEG PATELLA 35MM. 2323593 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM. 2329343 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM. 2336650 204-70-00 - TIBIAL STEM EXT. SCREW. 2337588 204-70-00 - TIBIAL STEM EXT. SCREW.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, F, G. THE REASON FOR THE REPORTED SURGERY DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. ADDITIONALLY, INFECTION IS A KNOWN SURGICAL RISK, AS OUTLINED IN THE IFU. 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 BY THE EXACTECH KNEE REPLACEMENT STUDY, THE 54 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2012 AND PRESENTED ON (B)(6) 2023 WITH INFECTION - SEPTIC LEFT TOTAL KNEE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. IT IS ALSO INDICATED THAT THE FOLLOWING ACTION(S) WERE TAKEN IRRIGATION/DEBRIDEMENT/IMPLANT REMOVAL/ANTIBIOTIC SPACER PREIMPLANTATION AFTER IV ANTIBIOTICS FOR 6 WEEKS. THE OUTCOME OF THIS EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2023. (B)(6) 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3. 510K: K033883. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260728 LOGIC FEMORAL PS CEM LEFT SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001146

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female SEE H10.