BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 5

    MDR report key: 17816598 · Received September 26, 2023

    Report

    Report Number
    1038671-2023-02373
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    September 1, 2023
    Report Date
    May 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001177
    PMA / PMN Number
    K101981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6: HEALTH EFFECT - COMPONENT CODE. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, B5, H6: HEALTH EFFECT - CLINICAL CODE. CONCOMITANTS: (B)(6) 02-012-35-5009 - LOGIC TIBIA PS MOD INSRT SZ 5 9MM. (B)(6) 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T. (B)(6) 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM. (B)(6) 204-70-00 - TIBIAL STEM EXT. SCREW.. (B)(6) 200-02-41 - THREE PEG PATELLA 41MM. (B)(6) 203-90-21 - (11-2716) 90X13/21X1.19MM.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T 2060439, 200-02-41 - THREE PEG PATELLA 41MM 2185331, 203-90-21 - (11-2716) HALL PWR PRO VRSPWR+ 90X13/21X1.19MM 32352, 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM 2360684, 204-70-00 - TIBIAL STEM EXT. SCREW 2467800, 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T 2060439.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO PROSTHESIS WEAR AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. A CONTRIBUTING FACTOR TO THE FEMORAL LOOSENING MAY HAVE BEEN DUE TO PATIENT-RELATED CONDITIONS. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, INCLUSION OF THE POLYETHYLENE IN THE RECALL, HIGH CONTACT STRESSES DURING KNEE FLEXION/EXTENSION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. 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

    IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A LOOSE FEMUR AND PROSTHESIS WEAR, PAIN, DISCOMFORT, SWELLING, AND GAIT IMPAIRMENT. NO OPERATIVE NOTES WERE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 54 YEAR OLD MALE PATIENT'S LEFT KNEE WAS REVISED DUE TO A LOOSE FEMUR AND A RECALLED POLY. PATIENT COMPLAINED OF PAIN. SURGEON USED COMPETITOR DEVICES DUE TO RECALL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723696 LOGIC FEMORAL PS CEM LEFT SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862001177

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention| H SEE H10.