BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 15499836 · Received September 28, 2022

    Report

    Report Number
    1038671-2022-01180
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    January 1, 2022
    Report Date
    August 19, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039583
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURNING DUE TO CLINICAL STUDY POLICIES. CONCOMITANTS: 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3, 02-012-43-3020 - LOGIC TIBIA RBKTRAY CEM SZ 3F/ 2T, 200-02-29 - THREE PEG PATELLA 29MM, 999 - FEMORAL STEM, 999 - FEMORAL AUGMENTS (DISTAL), 999 - FEMORAL AUGMENTS (POSTERIOR), 999 - TIBIAL STEM EXTENSION, 999 - TIBIAL AUGMENTATION, 999 - PROXIMAL TIBIAL SPACE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT PAIN CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3: (B)(6). 02-012-38-3009 - LOGIC TIBIA PS RBK INSRT SZ 3 9MM: (B)(6). 02-012-43-3020 - LOGIC TIBIA RBKTRAY CEM SZ 3F/ 2T: (B)(6). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, EXACTECH KNEE REPLACEMENT STUDY, THAT A 75 YO (B)(6) 2019 FOR PRIMARY INDICATION OF OSTEOARTHRITIS, REPORTED CONTINUOUS PAIN IN ANTERIOR SIDE. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES OR PROCEDURE. OUTCOME IS CONTINUING. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    UPDATED: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PATELLAR PAIN CONTINUOUS IN ANTERIOR SIDE AS WELL AS SUBLUXATION. AS A RESULT, APPROXIMATELY 3.5 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633656 OPTETRAK PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. THREE PEG PATELLA 29MM UNK 10885862039583

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention SEE H10| SEE H11