BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 8866158 · Received August 6, 2019

    Report

    Report Number
    1038671-2019-00407
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 29, 2019
    Report Date
    April 23, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE EVALUATION NOTED THAT THE REASON FOR THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. (D11)CONCOMITANT DEVICES: (CN: 02-012-45-1515, SN: 2529236) LOGIC FIT TRAY, SIZE 1.5F/1.5T (CN: 02-012-44-1511, SN: 2212077) LOGIC PSC INSERT, SIZE 1.5, NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A3, A4, A5, B6. THE FOLLOWING SECTION(S) HAVE ADDITIONAL INFO; G4, G7, H1, H2, H3, H6, AND H7.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3): PENDING EVALUATION. NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A3, A4, A5, B6 AND G5. THE FOLLOWING SECTION(S) HAVE ADDITIONAL INFO: B5, D4 (UDI NUMBER), D10, G4, G5, G7, H1, AND H2, (D11)CONCOMITANT DEVICES: (CN: (B)(4), SN:(B)(4) ) LOGIC FIT TRAY, SIZE 1.5F/1.5T. (CN: (B)(4), SN: (B)(4) ) LOGIC PSC INSERT, SIZE 1.5, 11MM.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: (CN: 02-012-45-1515, SN: (B)(4)) LOGIC FIT TRAY, SIZE 1.5F/1.5T; (CN: 02-012-44-1511, SN: (B)(4)) LOGIC PSC INSERT, SIZE 1.5, 11MM.

    Description of Event or Problem · 1

    AS REPORTED, INDEX SURGERY: (B)(6) 2013. REVISION OF THE RIGHT KNEE IMPLANTS, DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND POSSIBLY THE TIBIAL COMPONENTS; THEREFORE, THE COMPONENTS WERE EXPLANTED. THE PATELLAR COMPONENT WAS NOTED TO HAVE SIGNIFICANT WEAR BUT BECAUSE IT WAS WELL-FIXED, IT WAS ELECTED TO NOT REVISE THIS COMPONENT. DURING THE REVISION PROCEDURE, FEMORAL AND TIBIAL COMPONENTS WITH STEMS, OFFSET COUPLER, AND AUGMENTS WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE WELL AND LEFT THE OPERATING ROOM IN STABLE CONDITION. THE REP WAS PRESENT AT THE TIME OF THE SURGERY. THE DEVICES WILL BE RETURNED FOR EVALUATION UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661655 OPTETRAK LOGIC LOGIC TIN CR FEM POR RIGHT SZ 1.5 JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention