BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM

    MDR report key: 16657008 · Received March 31, 2023

    Report

    Report Number
    1038671-2023-00560
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    May 19, 2020
    Report Date
    January 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862063991
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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; DEVICE INFORMATION HAS NOT BEEN PROVIDED. THE CAUSE OF THE PATIENT¿S PAIN 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 THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE FOLLOWING SECTIONS WERE UPDATED: A2, A3. D4: EXPIRATION DATE D10 CONCOMITANTS: 1124784 244-02-03 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, LEFT, 1171178 200-02-32 - THREE PEG PATELLA 32MM, 1171895 204-04-32 - TRAPEZOID TIBIAL TRAY SZ 3F/2T, E1, G1, H4. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, AND TIBIAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL NOTIFICATION THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6), 2008. IN THE ENSUING TIME, THE PATIENT BEGAN TO SUFFER FROM SYMPTOMS INCLUDING PAIN AND LACK OF MOBILITY. AS A RESULT OF THESE SYMPTOMS, THE PATIENT UNDERWENT A REVISION OF THE LEFT TOTAL KNEE ON (B)(6), 2020, APPROXIMATELY 12 YEARS 3 MONTHS POST INITIAL PROCEDURE. THE PATIENT EXPERIENCES, PAIN, LACK OF MOBILITY, AND ENDURING LIMITATIONS ON ACTIVITIES OF DAILY LIVING, QUALITY OF LIFE AND ABILITY TO PERFORM WORK FUNCTIONS. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425348 OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. N/A UNK 10885862063991

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| H