BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHER R1 REVERSE SHOULDER SYSTEM

    MDR report key: 16294407 · Received February 3, 2023

    Report

    Report Number
    3012552981-2023-00009
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    January 24, 2023
    Report Date
    January 31, 2023
    Manufacturer
    CATALYST ORTHOSCIENCE INC
    Product Code
    PHX
    UDI-DI
    00811596030513
    PMA / PMN Number
    K202611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SHOULD ARTHROPLASTY SURGERY AND APPROXIMATELY 13 MONTHS LATER WAS REVISED DUE TO INSTABILITY AND DISLOCATION. DURING SURGERY IT WAS DISCOVERED THAT THE POLY INSERT WAS IN THE STEM, BUT COULD BE REMOVED BY HAND. THE POLY INSERT WAS EXPLANTED. THE PATIENT DID NOT REPORT ANY SPECIFIC EVENT THAT MAY HAVE CAUSED THE DISLOCATION. CUSTOMER HAS INDICATED THAT THE IMPLANT WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855797 ARCHER R1 REVERSE SHOULDER SYSTEM SHOULDER PROSTHESIS PHX CATALYST ORTHOSCIENCE INC 1230-7505-004 2109112 00811596030513

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention 1230-7505-004, LOT #2109112