BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 16366680 · Received February 13, 2023

    Report

    Report Number
    1038671-2023-00138
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    June 25, 2021
    Report Date
    October 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001160
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL POLYMER. CONCOMITANT MEDICAL PRODUCTS:¿ 4159329 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4, 4178111 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T, 4079517 200-02-38 - THREE PEG PATELLA 38MM, 4159869 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM, 4173166 204-70-00 - TIBIAL STEM EXT. SCREW. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5. H6 INVESTIGATION FINDINGS. H6. 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 PAIN AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    THE REASON THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF FEMORAL LOOSENING, PROSTHESIS WEAR, AND INSTABILITY. THE FEMORAL COMPONENT POSITIONING AND PATIENT-RELATED CONDITIONS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT BUT THE CONTRIBUTIONS OF THESE USER AND PATIENT-RELATED ISSUES TO THE SEQUENCE OF EVENTS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED, ON (B)(6) 2015, PATIENT UNDERWENT INITIAL LEFT KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH A OPTETRAK DEVICE. SPECIFICALLY, PLAINTIFF WAS IMPLANTED WITH A OPTETRAK POSTERIOR STABILIZED TIBIAL INSERT, ALONG WITH AN OPTETRAK STEM, OPTETRAK PATELLA, OPTETRAK SCREWS, A OPTETRAK TIBIAL TRAY, AND A OPTETRAK POSTERIOR STABILIZED FEMORAL COMPONENT. FOLLOWING THE SURGERY, PLAINTIFF BEGAN EXPERIENCING WORSENING SYMPTOMS, PAIN, INSTABILITY, EFFUSION, AND ANTALGIC GATE. PLAINTIFF UNDERWENT A LEFT KNEE REVISION SURGERY ON (B)(6) 2021, APPROXIMATELY 5 YEARS 6 MONTHS POST INITIAL PROCEDURE AND WAS IMPLANTED WITH ANOTHER RECALLED EXACTECH OPTETRAK DEVICE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517565 OPTETRAK LOGIC SEE H10 JWH EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 4 UNK 10885862001160

    Patients

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