BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 4 11MM

    MDR report key: 15679720 · Received October 27, 2022

    Report

    Report Number
    1038671-2022-01357
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    June 27, 2022
    Report Date
    October 12, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001894
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. RECALL #: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2 & B5. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.

    Additional Manufacturer Narrative · 0

    H6: RE-OPENED INVESTIGATION RESULTS: THE REVISION REPORTED WAS LIKELY THE RESULT OF POLYETHYLENE WEAR, AS STATED IN THE LEGAL DOCUMENTATION AND OPERATIVE NOTES, AFTER BEING IMPLANTED FOR OVER 12 YEARS. 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 POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RADIOGRAPHS AND PHOTOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2010. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO UNKNOWN REASONS. NO OTHER INFORMATION REPORTED.

    Description of Event or Problem · 0

    OPERATIVE REPORT OF 27 JUN 2022 [RELEVANT INFORMATION] PRE-OPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO ACCELERATED WEAR OF THE POLYETHYLENE BEARING SURFACE. PROCEDURE: REVISION LEFT TOTAL KNEE REPLACEMENT, FEMORAL COMPONENT, AND THE TIBIAL POLY. THE TIBIAL POLY WAS REMOVED AND INSPECTED, FOUND TO HAVE SIGNIFICANT WEAR IN THE MEDIAL AND LATERAL COMPARTMENTS. SYNOVITIS WAS THOROUGHLY REMOVED FROM THE SUPRAPATELLAR POUCH. A LARGE PSEUDOTUMOR OF HYPERTROPHIC SYNOVIUM PROJECTED BEHIND THE FEMORAL SHAFT, AND THERE WERE AREAS OF SYNOVIAL CYST FORMATION. A THOROUGH SYNOVECTOMY WAS PERFORMED. VERY MINIMAL OSTEOLYSIS IN THE DISTAL FEMUR. THE FEMORAL COMPONENT WAS WELL FIXED, BUT THE GROSS INSTABILITY ON THE POSTEROLATERAL CORNER REQUIRED THE USE OAF A CCK COMPONENT, FEMORAL COMPONENT REVISION WAS REQUIRED. NO COMPLICATIONS DURING THE PROCEDURE. DRESSINGS WERE APPLIED, THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM INSTABLE CONDITION. PRE OP X RAYS SHOWED WELL FIXED COMPONENTS, HE HAD RECURVATUM AND SIGNIFICANT SAGITTAL PLANE INSTABILITY AT 90 DEGREES OF FLEXION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573566 LOGIC TIBIA PS MOD INSRT SZ 4 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-35-4011 10885862001894

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention