BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 16701940 · Received April 7, 2023

    Report

    Report Number
    1038671-2023-00614
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    August 23, 2022
    Report Date
    June 1, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173720
    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

    CONCOMITANT MEDICAL PRODUCT(S): 02-010-01-0350 - 4180291 - LOGIC FEMORAL PS CEM RIGHT SZ 5; 02-012-41-5050 - 5108397 - LOGIC TIBIA TRAPTRAY CEM SZ 5F/5T; 200-02-32 - 5661792 - THREE PEG PATELLA 32MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    ADDED INFORMATION TO E3, E4, H7, AND H9. ADDED COMPONENT CODE TO H6. H6: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF POLYETHYLENE WEAR AS STATED IN THE OPERATIVE NOTES. THE EXTENT AND ROOT CAUSE OF THE POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, AND RADIOGRAPHS AND PHOTOGRAPHS WERE NOT PROVIDED. A CONTRIBUTING FACTOR TO THE POLYETHYLENE WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. H6: CORRECTED CLINICAL CODE, IMPACT CODE, AND PROBLEM CODE TO MORE ACCURATELY REFLECT THE REPORTED EVENT.

    Description of Event or Problem · 0

    LEGAL CASE - USA. PATIENT ID: (B)(6). IT WAS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2019 WITH NO COMPLICATIONS. ON (B)(6) 2022, APPROXIMATELY 3 YEARS 5 MONTHS FROM THE INITIAL, THE PATIENT RECEIVED A REVISED RIGHT KNEE REPLACEMENT DUE TO ¿THE PATIENT HAD MODERATE DEBRIS SYNOVITIS. IT WAS ACTUALLY NOT AS BAD AS THE PREVIOUS ARTHROSCOPY. THE FEMUR AND TIBIA WERE EVALUATED AND BOTH WERE INTACT WITHOUT ANY EVIDENCE OF LOOSENING." AN ARTHROSCOPY WAS PERFORMED ON (B)(6) 2022. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. 510K: K110547.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442179 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM UNK 10885862173720

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention