BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 18616220 · Received January 31, 2024

    Report

    Report Number
    1038671-2024-00143
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    December 27, 2023
    Report Date
    July 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    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): 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2: 3863635. 02-012-45-2010 - LGC TIBIAL FIT TRAY CEM SZ 2F / 1T: 4071036. 200-02-35 - THREE PEG PATELLA 35MM: 4122997. 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM: 4131719. 204-70-00 - TIBIAL STEM EXT. SCREW: 4123372.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, D4, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE REPORTED REVISION DUE TO INSTABILITY CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. SUBLUXATION AND DISLOCATION ARE KNOWN RISKS, 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 61 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2015 AND PRESENTED ON (B)(6) 2023 WITH INSTABILITY. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND AND/OR TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT A REVISION OF THE FOLLOWING COMPONENTS FEMORAL, TIBIAL INSERT; TOOK PLACE ON (B)(6) 2023 AND THE OUTCOME OF THIS EVENT WAS REPORTED AS CONTINUING. 02-012-35-2009 - LOGIC TIBIA PS MOD INSRT SZ 2 9MM: (B)(6). SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491048 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female SEE H10.