BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 4

    MDR report key: 17318274 · Received July 13, 2023

    Report

    Report Number
    1038671-2023-01650
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    June 22, 2023
    Report Date
    January 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001160
    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

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND FEMORAL LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 4092614 200-02-38 - THREE PEG PATELLA 38MM. 4143025 02-012-35-4013 - LOGIC TIBIA PS MOD INSRT SZ 4 13MM. 4143207 200-02-38 - THREE PEG PATELLA 38MM. 4205725 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM. 4205760 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM. 4210903 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T. 4210938 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T. 4214606 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4. 4233023 204-70-00 - TIBIAL STEM EXT. SCREW. 4233038 204-70-00 - TIBIAL STEM EXT. SCREW.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND FEMORAL LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. H6: CORRECTED HEALTH EFFECT CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 7 YEARS POST OP INITIAL LEFT TKA, THIS 61 Y/O MALE PATIENT WAS REVISED DUE TO LOOSE FEMUR AND RECALL OF THE TIBIAL INSERT. SURGEON REVISED TO A CONSTRAINED SIZE FOR FEMUR WITH EXTENSION, STEM AND FEMORAL AUGMENTS. ALSO A FEMORAL CONE & CC TIBIAL INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND IMAGES ATTACHED. NO PRODUCT RETURN; LAWYER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313462 LOGIC FEMORAL PS CEM LEFT SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862001160

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male SEE H10