BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 21069041 · Received January 3, 2025

    Report

    Report Number
    1038671-2025-00051
    Event Type
    Injury
    Date Received
    January 3, 2025
    Report Date
    May 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 300-01-10 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM: 6198784, 320-36-00 - 145-DEG PE 36MM HUM LINER +0: 7150049, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 7218435, 320-31-36 - GLENOSPHERE, 36MM: 7003056, 320-35-01 - SMALL GLENOID PLATE: 7249607. 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. 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

    A REVIEW OF THE STERILE CERTIFICATES AND/OR THE FINAL ENDOTOXIN TEST REPORTS WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO SUSPECTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. H6: CORRECTED HEALTH EFFECT AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DEEP INFECTION. PATIENT DEVELOPED PAIN AND SWELLING. NORMAL INFLAMMATORY MARKERS, CT SCAN. PLAN FOR I&D, CYST EXCISION, POLY SWAP AND IV ANTIBIOTICS. THE PATIENT IS PLANNED FOR I&D, CYST EXCISION, POLY SWAP AND IV ANTIBIOTICS. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430749 SPECIFIC DEVICE NOT REPORTED SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention SEE H11.