BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 17080679 · Received June 7, 2023

    Report

    Report Number
    1038671-2023-01277
    Event Type
    Injury
    Date Received
    June 7, 2023
    Date of Event
    March 20, 2023
    Report Date
    June 5, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173744
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. H6. INVESTIGATION RESULTS - THERE IS NO SPECIFIC INFORMATION PROVIDED FOR THE OPTETRAK LOGIC DEVICE. THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    H10. D10.CONCOMITANT MEDICAL PRODUCTS INFORMATION: OPTETRAK LOGIC CC FEMORAL SIZE 5 (02-010-06-0250, 4588495); OPTETRAK EXT STEM FEMUR (204-40-16, 3711516); SCREW BONE 7MM OPTETRAK TIB KNEE EXT STEM (204-70-00, 4743305); LOGIC POST. AUG. BLOCK SIZE 5 (02-010-06-0551, 4417039); LOGIC POST. AUG. BLOCK SIZE 5 (02-010-06-0551, 4544403) UPDATED/ADDITIONAL INFORMATION ¿ A2. A3. D4. G1. G2. G4. H4. H6. H7. H9. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND OSTEOLYSIS. 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 OSTEOLYSIS COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE- B5 ADDITIONAL INFORMATION, H6. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A FIRST LEFT KNEE ARTHROPLASTY REVISION ON (B)(6) 2017 AND THEN APPROXIMATELY 5 YEARS LATER WAS REVISED FOR A SECOND TIME ON (B)(6) 2023 FOR OSTEOLYSIS, BONE LOSS, SYNOVITIS COMPONENT LOOSENING, POLYWEAR AND DEBONDING, INSTABILITY, JOINT PAIN, STIFFNESS, AND SWELLING, FOREIGN BODY REACTION SYNOVITIS: INSUFFICIENT INFORMATION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    REVISION OP REPORT - DIAGNOSIS: LEFT KNEE POLYETHYLENE FAILURE FINDINGS: POLY WEAR AND DEBONDING, OSTEOLYSIS. THE ENTIRE JOINT WAS INSPECTED SHOWING SIGNIFICANT OSTEOLYTIC SYNOVITIS. CHRONICALLY INFLAMED SYNOVIUM WAS RESECTED FROM THE SUPRAPATELLAR POUCH AND ANTERIOR SURFACE OF THE BONY FEMUR. THE PATIENT ARRIVED IN PACU IN STABLE CONDITION WITH NO APPARENT COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482102 OPTETRAK LOGIC SEE H10 JWH EXACTECH, INC. 10885862173744

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention SEE H10