BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENTED FINNED TIB. TRA SZ 3F/3T

    MDR report key: 20982616 · Received December 19, 2024

    Report

    Report Number
    1038671-2024-04967
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    January 11, 2019
    Report Date
    January 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1038671-2024-00021. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS). THE FOLLOWING SECTIONS WERE CORRECTED: H6 (HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE). THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, TIBIAL LOOSENING, AND INSTABILITY. OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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

    D10: 1513137 234-03-03 - OPTETRAK ASY, PS CEMENTED FEMORAL, SZ 3, 1522795 200-02-29 - THREE PEG PATELLA 29MM. 1553085 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-00021. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION A PATIENT UNDERWENT A RIGHT TOTAL KNEE REVISION SURGERY TO ADDRESS PROTHESIS WEAR, INSTABILITY AND HARDWARE FAILURE OF THE RIGHT KNEE. A REVISION OP REPORT WAS PROVIDED. INTRAOPERATIVELY THE SURGEON OBSERVED SIGNIFICANT SYNOVITIS DUE TO OSTEOLYSIS AND PARTICLE DISEASE. IT WAS NOTED THERE WAS NO EVIDENCE OF ACUTE INFLAMMATION. THE TIBIAL COMPONENT WAS NOTED AS LOOSE. THERE WERE MEDICAL OR SURGICAL INTERVENTIONS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 510(K): K933610. RECALL: Z-0020-2022. CONCOMITANTS:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512921 CEMENTED FINNED TIB. TRA SZ 3F/3T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention| H