BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 8930041 · Received August 26, 2019

    Report

    Report Number
    1038671-2019-00418
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    December 15, 2015
    Report Date
    March 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K932776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE EVALUATION NOTED IN THE REVISION REPORTED WAS LIKELY THE RESULT OF EITHER PATIENT CONDITIONS, AN INSUFFICIENT BOND BETWEEN THE TIBIAL TRAY AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) TIBIAL LOOSENING, OR A COMBINATION OF THE TWO. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTS WERE NOT RETURNED FOR EVALUATION. (D11)CONCOMITANT DEVICES: - LOGIC TIBIA PS MOD INSRT SZ 2 9MM (CN: 02-012-35-2009, SN: (B)(6)) - LOGIC FEMORAL PS CEM RIGHT SZ 2 (CN: 02-010-01-0320 , SN: (B)(6)) - THREE PEG PATELLA (CN: 200-02-35 , SN: (B)(6)). NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A5.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL INFORMATION. H3. UPDATED INVESTIGATION -THE REVISION REPORTED IN MAY HAVE BEEN THE RESULT OF POLYETHYLENE WEAR AND ASEPTIC TIBIAL LOOSENING. THE ASEPTIC (NON-INFECTED) TIBIAL LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE TIBIAL TRAY AND THE BONE. THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS/PHOTOGRAPHS WERE NOT PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: LOGIC TIBIA PS MOD INSRT SZ 2 9MM (CN: 02-012-35-2009, SN: (B)(4)); LOGIC FEMORAL PS CEM RIGHT SZ 2 (CN: 02-010-01-0320, SN: (B)(4)); THREE PEG PATELLA (CN: 200-02-35 , SN: (B)(4)).

    Description of Event or Problem · 1

    THE AWARE WILL BE 15 AUG 2019. THIS PROJECT WAS TO FIND THE INFORMATION SUBMITTED BY DR. (B)(6) TO CASES ALREADY ENTERED INTO THE EXACTECH COMPLAINT SYSTEM. THERE HAS BEEN RESEARCH INTO THE CURRENT ELECTRONIC COMPLAINT HANDLING SYSTEM, THE (B)(6) COMPLAINT HANDLING SPREADSHEETS, AND THE MOST RECENT BACKLOG 2018-2019 COMPLAINT HANDLING SPREADSHEET TO FIND MATCHING COMPLAINT INFORMATION. THIS PATIENT HAS NO MATCH TO ANY OF THE INFORMATION WE HAVE. CLINICAL SUMMARY: IT WAS REPORTED THAT AN OBESE (B)(6) YO FEMALE EXPERIENCED A RIGHT KNEE REVISION ON (B)(6) 2015, DUE TO LOOSENING. THE PATIENT WAS TAKEN TO THE PACU IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. PREOPERATIVE DIAGNOSIS-LOOSE RIGHT TOTAL KNEE TIBIAL COMPONENT POSTOPERATIVE DIAGNOSIS- LOOSE RIGHT KNEE TIBIAL COMPONENT. INDICATION-FEMUR AND TIBIA WITH SUBSIDED TO LOOSENING OF TIBIA AND PERSISTENT PAIN AND SOME VARUS DEFORMITY OF THE TIBIA. NEGATIVE FOR INFECTION. FINDINGS- THE TIBIA WAS LOOSE AND SHOWED GROSS MOTION. PATIENT INFORMATION- (B)(6). RELEVANT MEDICAL HISTORY- INITIAL RIGHT TKA (B)(6) 2010 FOR DEGENERATIVE JOINT DISEASE, RIGHT KNEE ARTHRITIS RESISTANT TO CONSERVATIVE MEASURES. HYPERTENSION & DIABETES. CLINICAL RISKS FOR THIS PATIENT INCLUDED OBESITY WHICH CAN CAUSE A BIOMECHANICAL OVERLOAD AND CREATION OF STRESSORS ON THE NATURAL AND IMPLANTED JOINT DEVICES. HYPERTENSION AND DIABETES AFFECT HEALING AND TISSUE MATRIX. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724767 OPTETRAK LOGIC LOGIC TIBIA FIN TRAY CEM SZ 2F/2T JWH EXACTECH, INC.

    Patients

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