BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHER R1 REVERSE SHOULDER SYSTEM

    MDR report key: 13722506 · Received March 10, 2022

    Report

    Report Number
    3012552981-2022-00004
    Event Type
    Injury
    Date Received
    March 10, 2022
    Date of Event
    February 11, 2022
    Report Date
    February 24, 2022
    Manufacturer
    CATALYST ORTHOSCIENCE INC
    Product Code
    PHX
    UDI-DI
    00811596030506
    PMA / PMN Number
    K202611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT: POLY INSERT IMPLANT SIZE 40 +8, 1230-7505-003, LOT # 2105624. 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

    HOLD FOR KP 3.10IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SHOULDER ARTHROPLASTY AND APPROXIMATELY 02 MONTHS LATER WAS REVISED DUE TO DISSOCIATION OF THE HUMERAL INSERT FROM THE HUMERAL STEM. THE PREVIOUS HUMERAL INSERT AND HUMERAL STEM WERE REPLACED WITH A NEW INSERT AND STEM. 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. CUSTOMER HAS INDICATED THAT 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
    1622867 ARCHER R1 REVERSE SHOULDER SYSTEM SHOULDER PROSTHESIS PHX CATALYST ORTHOSCIENCE INC 1230-7505-003 2105624 00811596030506

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 1230-7505-003, LOT # 2105624