BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METAL KNEE COMPONENT

    MDR report key: 22149043 · Received June 5, 2025

    Report

    Report Number
    1038671-2025-02224
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    February 3, 2015
    Report Date
    June 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: (B)(6) - 208-22-18 - CC TIBIAL INSERT SZ 2, 18MM; (B)(6) - 208-01-02 - CC FEMORAL SZ 2; (B)(6) - 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE; (B)(6) - 204-04-22 - TRAPEZOID TIBIAL TRAY SZ 1F/2T, 2F/2T; (B)(6) - 204-36-08 - STEM EXTENSION 80L X16 MM; (B)(6) - 204-36-12 - STEM EXTENSION W/SLOT 120L X16 MM; (B)(6) - 204-62-88 - TIBIAL AUGMENT BLOCK 1/2-SZ 2 11MM RLLM; (B)(6) - 204-62-89 - TIBIAL AUGMENT BLOCK 1/2-SZ 2 11MM LLRM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-03639. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION 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 VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 6 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, MENTAL AND EMOTIONAL DISTRESS. NO REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80384 UNKNOWN METAL KNEE COMPONENT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.