BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 15346911 · Received September 2, 2022

    Report

    Report Number
    1038671-2022-01009
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    July 30, 2019
    Report Date
    May 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001894
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED VIA LEGAL CHANNELS THAT INCLUDE OP-REPORTS AND PRODUCT INFORMATION. REPORT HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION AND THE INVESTIGATION HAS BEEN RE-OPENED. D10. CONCOMITANTS: 2122806, 200-02-35, THREE PEG PATELLA 35MM. 2075238, 02-012-41-4040, LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T. 2098497, 02-010-01-0340, LOGIC FEMORAL PS CEM RIGHT SZ 4.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF POLYETHYLENE WEAR AND OSTEOLYSIS AS STATED IN THE LEGAL DOCUMENTATION AND OPERATIVE NOTES. THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND PRE-REVISION RADIOGRAPHS AND IMAGES OF THE EXPLANTED DEVICES WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL FILING THAT MALE PATIENT WHO HAD INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2011 IN WHICH HE WAS IMPLANTED WITH OPTETRAK DEVICES, HAD REVISION SURGERY APPROXIMATELY 10 YEARS 3 MONTHS POST THE INITIAL IMPLANT PROCEDURE DUE TO THE PREMATURE FAILURE OF THE OPTETRAK IMPLANTS. THE FAILED COMPONENTS WERE REMOVED. UPON INFORMATION AND BELIEF, PLAINTIFF REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY AND/OR COMPONENT LOOSENING. PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS KNEE WHICH LIMITS HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE. AS A DIRECT, PROXIMATE AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE AS DESCRIBED HEREIN, PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. 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 REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445465 OPTETRAK PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 11MM UNK 10885862001894

    Patients

    Seq Age Sex Outcome Treatment
    1