BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 6 11MM

    MDR report key: 19177891 · Received April 24, 2024

    Report

    Report Number
    1038671-2024-00974
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    April 2, 2024
    Report Date
    July 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001979
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): (B)(6): 02-010-01-0260 - LOGIC FEMORAL PS CEM LEFT SZ 6. (B)(6): 02-012-45-6050 - LGC TIBIAL FIT TRAY CEM SZ 6F / 5T. (B)(6): 200-02-38 - THREE PEG PATELLA 38MM.

    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/D2A/D2B, D4, D6B, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. 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, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2014. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO KNEE PAIN AND INSTABILITY AND THE POLY WAS EXCHANGED FOR A PSC 13MM. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605813 LOGIC TIBIA PS MOD INSRT SZ 6 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862001979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10