BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 13MM

    MDR report key: 19267502 · Received May 8, 2024

    Report

    Report Number
    1038671-2024-01115
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    February 19, 2024
    Report Date
    November 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862064011
    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

    (B)(6) 244-23-13 - OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 13MM. D10 CONCOMITANT DEVICES (B)(6) 244-02-03 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, LEFT. (B)(6) 204-04-33 - TRAPEZOID TIBIAL TRAY SZ 3F/3T. (B)(6) 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM. (B)(6) 200-02-35 - THREE PEG PATELLA 35MM. (B)(6) 204-70-00 - TIBIAL STEM EXT. SCREW. 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 DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. CORRECTED SECTION D, SECTION H6 CODES ADDED, SECTION H10 UPDATED.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 0740467 204-70-00 - TIBIAL STEM EXT. SCREW 0801199 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM 1227107 244-23-13 - OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 13MM 1355158 244-02-03 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, LEFT 1366942 244-23-11 - OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 11MM 1391340 204-04-33 - TRAPEZOID TIBIAL TRAY SZ 3F/3T 1394064 244-03-03 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, RIGHT 1405127 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM 1408388 200-02-35 - THREE PEG PATELLA 35MM 1413875 200-02-35 - THREE PEG PATELLA 35MM 1414481 204-04-33 - TRAPEZOID TIBIAL TRAY SZ 3F/3T 1419726 204-70-00 - TIBIAL STEM EXT. SCREW" THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    REPORT NUMBERS: 1038671-2024-03043, 1038671-2024-03056, 1038671-2024-03044 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, BONE FRACTURE, TIBIAL LOOSENING, AND FAILURE OF THE CEMENT TO SECURE TO FEMORAL COMPONENT, LEADING TO FEMORAL LOOSENING. AN ADDITIONAL CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 181 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN AND BONE FRACTURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 181 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND SEVERE PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772128 OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862064011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H