BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 16618123 · Received March 27, 2023

    Report

    Report Number
    1038671-2023-00515
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    January 1, 2015
    Report Date
    August 23, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862266163
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. 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 HEALING AND THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 02-010-06-0240 - LOGIC CC FEMORAL SIZE 4, LEFT, 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T, 02-012-60-1680 - LOGIC STEM EXT 16MM X 80MM AND 02-012-60-1612 - LOGIC STEM EXT 16MM X 120MM. PMA/510K: K150890.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 56 YO MALE PATIENT HAD AN INFECTED WOUND AND EXPERIENCED PAIN, SWELLING AND DRAINAGE FROM INCISION DUE TO INFECTED HEMATOMA. THE EVENT RESULTED IN, INPATIENT/PROLONGED HOSPITALIZATION; MEDICAL/SURGICAL INTERVENTION. THE PATIENT WAS REVISED ON (B)(6) 2015. THE PATIENT TREATMENT WAS RADICAL DEBRIDEMENT AND EXTENSIVE IRRIGATION. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-2015. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739744 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC CC TIB INSERT SIZE 4, 21MM UNK 10885862266163

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other| R SEE H10