BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2 9MM

    MDR report key: 18315414 · Received December 12, 2023

    Report

    Report Number
    1038671-2023-02965
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    January 1, 2023
    Report Date
    May 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001726
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 4033513 02-010-01-0320 - FEMUR PS CEM.Nº2 DER. 4020621 02-012-45-2030 - BANDEJA TIBIAL LOGIC FIT 2F/3T 4175455 204-34-04 - VASTAGO EXT. 14X40MM 4144601 204-70-00 - TORNILLO FIJACION VÁSTAGO A TIBIA H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H3: THE PROSTHESIS WEAR REPORTED MAY HAVE BEEN DUE TO THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, AND/OR MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS. 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. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 CLINICAL CODE, H6 COMPONENT CODE, H6 INVESTIGATION FINDINGS, H6 INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PROSTHESIS WEAR REPORTED MAY HAVE BEEN DUE TO THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, AND/OR MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS. 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. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS WERE NOT 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

    DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. ON 28-NOV-2023 UPDATES TO THE EXCEL LISTING WERE PROVIDED. THIS PATIENT (B)(6) WAS IMPLANTED WITH A 02-012-35-2009 LOGIC TIBIA PS MOD INSRT SZ 2 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2016. THE INSERT WAS MANUFACTURED ON 10/22/2015 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 10/22/2015 AND WAS 0.27 YEARS SHELF AGE AT THE TIME OF IMPLANT. PENDING REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525730 LOGIC TIBIA PS MOD INSRT SZ 2 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001726

    Patients

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