BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHER R1 REVERSE SHOULDER SYSTEM

    MDR report key: 22479727 · Received July 11, 2025

    Report

    Report Number
    3012552981-2025-00123
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 13, 2025
    Report Date
    July 10, 2025
    Manufacturer
    CATALYST ORTHOSCIENCE INC.
    Product Code
    PHX
    PMA / PMN Number
    K202611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS CONTACTED FOR ADDITIONAL DETAILS ON 06/26/2025. BASED ON THE DISCUSSION: THE PATIENT DID NOT EXPERIENCE PAIN. THE DISASSOCIATION WAS IDENTIFIED THROUGH X-RAY IN A FOLLOW UP MEETING ABOUT 3-4 WEEKS FOLLOWING IMPLANTATION. THE SURGERY WAS ON (B)(6) 2025 AND THEN REVISED ON (B)(6) 2025. THERE WERE NO SIGNS OF PATIENT NONCOMPLIANCE FOLLOWING THE SURGERY NOR WERE ANY PATIENT FALLS NOTED. AFTER IMPLANTING THE POLY, THE SURGEON VISUALLY INSPECTED THE RIM TO CHECK FOR PROPER SEATING. THE DEVICE WAS RETURNED AND INSPECTED. THE RING END WAS STUCK IN THE POLY SLOT AND WOULD NOT MOVE. THE METAL RING WAS STILL INTACT WITH MINIMAL SIGNS OF DAMAGE. THE ONLY NOTED DAMAGE ON THE RING WAS A SLIGHT BEND ON ONE END, INDICATING THAT THE DEVICE WAS NOT FULLY SEATED INTO THE STEM. THE DHR WAS REVIEWED AND NO NONCONFORMANCES RELATED TO THE FAILURE WERE NOTED. BASED ON THE INVESTIGATION IT WAS CONCLUDED THAT THE DEVICE WAS NOT FULLY SEATED.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO POLY DISASSOCIATION WHICH WAS IDENTIFIED THROUGH AN X-RAY IMAGE DURING A FOLLOW-UP MEETING APPROXIMATELY 3-4 WEEKS FOLLOWING DEVICE IMPLANTATION. THE SURGERY WAS ON (B)(6) 2025 AND WAS LATER REVISED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653890 ARCHER R1 REVERSE SHOULDER SYSTEM SHOULDER PROSTHESIS PHX CATALYST ORTHOSCIENCE INC. 1230-7530-002 273568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention