BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 21438644 · Received February 21, 2025

    Report

    Report Number
    1038671-2025-01139
    Event Type
    Death
    Date Received
    February 21, 2025
    Report Date
    April 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT EVENT WAS RECEIVED VIA KROLL CLAIM (CLAIMS RECEIVED AS PART OF EXACTECH'S FINANCIAL RESTRUCTURING PROCESS, MANAGED BY KROLL, LLC). ALL AVAILABLE EVENT AND PRODUCT INFORMATION WAS COLLECTED AT THE TIME OF CLAIM INTAKE; NO FURTHER INFORMATION IS AVAILABLE OR EXPECTED. DUE TO THE LIMITED INFORMATION, THIS COMPLAINT EVENT CANNOT BE FURTHER INVESTIGATED OR CONFIRMED, AND A DEFINITIVE CAUSE CANNOT BE DETERMINED. POTENTIAL PRODUCT, PATIENT, AND/OR USER-RELATED CONTRIBUTING FACTORS CANNOT BE DEFINITIVELY DETERMINED. THERE IS NO INDICATION WITHIN THE AVAILABLE INFORMATION THAT A NEW OR UNEXPECTED FAILURE MODE OR HARM/ADVERSE EVENT TYPE HAS OCCURRED OR THAT THE BENEFIT-RISK ANALYSIS FOR EXACTECH PRODUCTS HAS BEEN ALTERED; THEREFORE, NO FURTHER RISK ANALYSIS WILL BE PERFORMED. HOWEVER, THIS EVENT WILL BE INCLUDED IN COMPLAINT TRENDING PER (B)(4) COMPLAINT TRENDING AND ACTIONS WILL BE TAKEN AS REQUIRED UPON DETECTION OF ANY TREND SIGNALS. NO FURTHER ACTION OR ESCALATION WILL BE TAKEN AT THIS TIME CONCERNING THIS REPORTED EVENT. SHOULD ADDITIONAL, RELEVANT INFORMATION BE RECEIVED CONCERNING THIS EVENT, THE COMPLAINT INVESTIGATION WILL BE RE-OPENED AND ACTIONS TAKEN AS APPROPRIATE. D1: CORRECTED. H6: CORRECTED HEALTH EFFECT AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    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 THIS PATIENT'S KNEE WAS REVISED. PATIENT SUFFERED FROM AN INFECTION, WHICH RESULTED IN THE REMOVAL OF HIS LEG IMPLANT AND ULTIMATELY RESULTED IN HIS PASSING. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693190 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H| D