BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHER R1 REVERSE SHOULDER SYSTEM

    MDR report key: 14438169 · Received May 19, 2022

    Report

    Report Number
    3012552981-2022-00015
    Event Type
    Injury
    Date Received
    May 19, 2022
    Report Date
    May 18, 2022
    Manufacturer
    CATALYST ORTHOSCIENCE INC
    Product Code
    PHX
    PMA / PMN Number
    K202611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT: POLY INSERT IMPLANT SIZE 40 +12, 1230-7505-004, LOT # 2105626. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE INVESTIGATION IS ONGOING. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SHOULDER ARTHROPLASTY AND APPROXIMATELY 02 MONTHS LATER WAS REVISED AGAIN DUE TO DISSOCIATION OF THE HUMERAL INSERT FROM THE HUMERAL STEM. THE PREVIOUS HUMERAL INSERT AND HUMERAL STEM WERE REPLACED WITH ANOTHER MANUFACTURER'S IMPLANT. THE PATIENT DID NOT REPORT ANY SPECIFIC EVENT THAT MAY HAVE CAUSED THE DISSOCIATION OF THE INSERT. ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE IMPLANTS WILL NOT BE RETURNED FOR INVESTIGATION AS THE IMPLANTS WERE DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293932 ARCHER R1 REVERSE SHOULDER SYSTEM SHOULDER PROSTHESIS PHX CATALYST ORTHOSCIENCE INC 1230-7505-004 2105626

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention 1230-7505-004, LOT 2105626.