BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 2

    MDR report key: 15624743 · Received October 18, 2022

    Report

    Report Number
    1038671-2022-01314
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    March 24, 2022
    Report Date
    December 22, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001122
    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

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 02-012-35-2009 - LOGIC TIBIA PS MOD INSRT SZ 2 9MM, (B)(4). NOTE: CANNOT DETERMINE WHICH INSERT IS LEFT OR RIGHT. INDEX SURGERY WAS BILATERAL. SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. MANUFACTURER DATE: 08/10/11, EXPIRATION DATE: 08/09/19. SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. MANUFACTURER DATE: 08/10/11, EXPIRATION DATE: 08/09/19. 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2 2132461; 02-012-35-2009 - LOGIC TIBIA PS MOD INSRT SZ 2 9MM 02-012-45-2010 - LGC TIBIAL FIT TRAY CEM SZ 2F / 1T 2061405, 2094065; 200-02-32 - THREE PEG PATELLA 32MM 2150093, 2155023; 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM 1899163, 2098463; 204-70-00 - TIBIAL STEM EXT. SCREW 2149170, 2156288.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING OVER 11 YEARS OF IMPLANTATION SECONDARY TO CONTRIBUTIONS FROM PATIENT CONDITIONS. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 11 YEARS POST OP THE INITIAL TSA, THIS 78 Y/O FEMALE PATIENT WAS REVISED DUE TO ASEPTIC FEMORAL LOOSENING, FEMORAL COMPONENT LOOSENING WITH LATERAL FEMORAL CONDYLE OSTEOLYSIS. PATIENT REVISED FEMORAL AND TIBIAL INSERT. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND UNLIKELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. OUTCOME IS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378200 LOGIC FEMORAL PS CEM LEFT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-010-01-0220 UNK 10885862001122

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention