BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 16546117 · Received March 15, 2023

    Report

    Report Number
    1038671-2023-00444
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    September 3, 2018
    Report Date
    September 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CORRECTED HEALTH EFFECT - IMPACT CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. MANUFACTURER NARRATIVE UPDATED: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY PRODUCT PROBLEMS OR USE ISSUES. THE CAUSE OF THE INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE REPORTED INFECTION MAY HAVE BEEN RELATED TO SEVERAL POTENTIAL FACTORS INCLUDING BUT NOT LIMITED TO THE SURGICAL PROCEDURE ITSELF, POST OP WOUND CARE, AND/OR PATIENT MEDICAL CONDITIONS.

    Additional Manufacturer Narrative · 0

    H3: 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; NO DEVICE INFORMATION WAS PROVIDED. THE CAUSE OF THE PATIENT¿S INFECTION 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

    CONCOMITANTS MEDICAL PRODUCTS: SERIAL #: (B)(4), CATEGORY #: 208-05-05 - CC DISTAL FEM AUGMENT SZ 5, 5MM. SERIAL #: (B)(4), CATEGORY #: 208-05-05 - CC DISTAL FEM AUGMENT SZ 5, 5MM. SERIAL #: (B)(4), CATEGORY #: 02-010-06-0551 - LOGIC POST. AUG. BLOCK SIZE 5, 5MM. SERIAL #: (B)(4), CATEGORY #: 02-010-06-0350 - LOGIC CC FEMORAL SIZE 5, RIGHT. SERIAL #: (B)(4), CATEGORY #: 400-40-11 - FLEX OSTEOTOME-ROUND, ME. SERIAL #: (B)(4), CATEGORY #: 02-012-60-1440 - LOGIC STEM EXT 14MM X 40MM. SERIAL #: (B)(4), CATEGORY #: 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. SERIAL #: (B)(4), CATEGORY #: 02-012-61-4202 - LOGIC OFF STM EXT 20MM X 120L X 4MM OFFSET. SERIAL #: (B)(4), CATEGORY #: 02-012-66-2000 - METAPHYSEAL TIBIAL CONE, ML32MM.

    Description of Event or Problem · 0

    IT WAS REPORTED POST-OPERATIVE VIA CLINICAL STUDY THAT THE 55 YO MALE PATIENT UNDERWENT REVISION SURGERY OF PRIMARY TOTAL KNEE ON (B)(6) 2018 DUE TO AN INFECTION (RIGHT KNEE I&D WITH LINER EXCHANGE). THE DATE OF EVENT ONSET IS (B)(6) 2018. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037565 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other| R SEE H10.