BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK

    MDR report key: 15346924 · Received September 2, 2022

    Report

    Report Number
    1038671-2022-01010
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    July 21, 2022
    Report Date
    April 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173492
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION- A2, B1, B5, B6, D4 ALL, D10, E3, G4 510K, H4, H6. TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, H7, & H9. D10. CONCOMITANTS: OPTETRAK LOGIC FEMORAL COMPONENT (02-010-01-0320, 2811278). OPTETRAK LOGIC TIBIAL TRAY (02-012-41-2010, 2487165). EXACTECH PATELLA 3 PEG (200-02-32, 2776640). H6. INVESTIGATION RESULTS-THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO WEAR OF THE POLYETHYLENE INSERT. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICE AND PRE-REVISION RADIOGRAPHS WERE NOT PROVIDED. THESE DEVICES ARE FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL FILING THAT A FEMALE PATIENT WHO HAD AN INITIAL RIGHT KNEE IMPLANT PROCEDURE ON (B)(6) 2013, CLAIMED SHE SUSTAINED INJURIES RESULTING FROM HER KNEE PROSTHESIS, AND WAS REVISED APPROXIMATELY 8 YEARS AND 8 MONTHS POST HER INITIAL PROCEDURE. NO FURTHER INFORMATION KNOWN. 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 FOR CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION-REVISION OPERATIVE REPORT OF (B)(6) 2022-POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO WEAR OF THE BEARING SURFACE.PATIENT CAME TO PHYSICIAN DUE TO INCREASING SWELLING. EXAM SUGGESTED HYPERTROPHIC SYNOVITIS WITH LARGE SYNOVIAL EFFUSION. SYNOVIAL FLUID WAS ASPIRATED AND SHOWED WHITE BLOOD CELL COUNT WAS LOW WITH PREDOMINANTLY LYMPHOCYTES AND MONOCYTES. DURING SURGERY, EXUBERANT SYNOVITIS WITH SIGNIFICANT SYNOVIAL LINING HYPERTROPHY. TIBIAL POLYETHYLENE INSERT WAS REMOVED AND INSPECTED AND THERE WAS MODERATE WEAR OF BOTH THE MEDIAL AND LATERAL ARTICULAR SURFACES. NO COMPLICATIONS.THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831838 OPTETRAK PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. UNK UNK 10885862173492

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention SEE H10