BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 8863939 · Received August 6, 2019

    Report

    Report Number
    1038671-2019-00392
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    April 17, 2019
    Report Date
    September 17, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K150890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D11) CONCOMITANT DEVICE: (CN: 02-010-06-0531, SN: (B)(6)) - LOGIC POST. AUG. BLOCK SIZE 3, 5MM; (CN: 02-010-06-0330, SN: (B)(6)) - LOGIC CC FEMORAL SIZE 3, RIGHT; (CN: 02-010-06-0531, SN: (B)(6)) - LOGIC POST. AUG. BLOCK SIZE 3, 5MM; (CN: 02-012-60-2080, SN:(B)(6)) - LOGIC STEM EXT 20MM X 80MM; (CN: 02-012-45-3030, SN: (B)(6)) - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T; (CN: 02-012-61-4000, SN: (B)(6)) - LOGIC OFFSET STEM EXT COUPLER 4MM; (CN: 02-012-60-2280, SN: (B)(6)) - LOGIC STEM EXT 22MM X 80MM. (H3) THE ENGINEERING EVALUATION NOTED THE INSTABILITY REPORTED WAS LIKELY THE RESULT OF INCREASED SOFT-TISSUE LAXITY (LOOSENESS), INADEQUATE FLEXION OF THE IMPLANTS, OR IMPROPER POSITIONING OR ALIGNMENT OF THE PROSTHESES. INSTABILITY OCCURS WHEN THE SOFT-TISSUE STRUCTURES AROUND THE KNEE ARE UNABLE TO PROVIDE THE STABILITY NECESSARY FOR ADEQUATE FUNCTION DURING STANDING OR WALKING. INSTABILITY MAY BE THE RESULT OF INCREASED SOFT-TISSUE LAXITY (LOOSENESS), INADEQUATE FLEXION OF THE IMPLANTS, OR IMPROPER POSITIONING OR ALIGNMENT OF THE PROSTHESES. PAIN AND/OR A SENSE OF ¿GIVING AWAY¿ OF THE KNEE MAY ALTER KNEE FUNCTION AND REQUIRE REVISION SURGERY. THE EVENT REPORTED WAS FOR MEDIAL LATERAL INSTABILITY. THEREFORE, A REVIEW OF THE DHR AND/OR THE STERILIZATION RECORDS WAS NOT CONDUCTED BECAUSE THE EVENT AS DESCRIBED IS A CLINICAL EVENT THAT DOES NOT APPEAR TO BE RELATED TO THE DESIGN, MANUFACTURING, OR REASONABLY FORESEEABLE MISUSE OF THE DEVICE. POSSIBLE CAUSES OF INSTABILITY ARE LISTED IN RMR 750-2011-032-RMR-IMPLANTS REV. F.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    INDEX SURGERY OF PRIMARY TOTAL KNEE: (B)(6) 2016. THE PATIENT CAME IN WITH COMPLAINTS OF INSTABILITY OF RIGHT KNEE. PHYSICAL THERAPY DONE FOR 3 MONTHS WITH NO CHANGE. HINGED KNEE BRACE PLACED. THE CASE REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. THE CASE REPORT INDICATES THE PATIENT OUTCOME IS STILL CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661739 OPTETRAK LOGIC LOGIC CC TIB INSERT SIZE 3, 21MM JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other SEE H10.