BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 15MM

    MDR report key: 19296357 · Received May 13, 2024

    Report

    Report Number
    1038671-2024-01189
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    April 22, 2024
    Report Date
    December 20, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001832
    PMA / PMN Number
    K033883
    Adverse Event
    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/OR CORRECTED INFORMATION. THE REVISION REPORTED IN CASE-(B)(4) WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND BONE WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING AND PAIN AFTER 12 YEARS OF IMPLANTATION. HOWEVER, POTENTIAL CONTRIBUTIONS FROM PROSTHESIS WEAR, AND/OR PATIENT-RELATED CONDITIONS TO THE REPORTED EVENT CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND LIMITED INFORMATION WAS PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 2025335, 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T, 2184803, 200-02-32 - THREE PEG PATELLA 32MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 2189770, 02-012-35-3013 - LOGIC TIBIA PS MOD INSRT SZ 3 13MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 2191764, 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T, 2195603, 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3, 2223753 ,200-02-32 - THREE PEG PATELLA 32MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND BONE WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING AND PAIN AFTER 12 YEARS OF IMPLANTATION. HOWEVER, POTENTIAL CONTRIBUTIONS FROM PROSTHESIS WEAR, AND/OR PATIENT-RELATED CONDITIONS TO THE REPORTED EVENT CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND LIMITED INFORMATION WAS PROVIDED. 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 THIS 63 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 12 YEARS POST OP INITIAL SURGERY. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458439 LOGIC TIBIA PS MOD INSRT SZ 3 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862001832

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention SEE H10