BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHER R1 REVERSE SHOULDER SYSTEM

    MDR report key: 15323357 · Received August 30, 2022

    Report

    Report Number
    3012552981-2022-00019
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    August 5, 2022
    Report Date
    November 18, 2022
    Manufacturer
    CATALYST ORTHOSCIENCE INC
    Product Code
    PHX
    PMA / PMN Number
    K202611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT: POLY INSERT IMPLANT SIZE 40 MM +4, 1230-7505-002, LOT # UNKNOWN. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE INVESTIGATION IS ONGOING. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT: POLY INSERT IMPLANT SIZE 40MM +4, 1230-7505-002, LOT # 2105622. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE INVESTIGATION IS ONGOING. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CORRECTED DATA, LOT NUMBER ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SHOULDER ARTHROPLASTY AND APPROXIMATELY 08 MONTHS LATER WAS REVISED DUE TO DISSOCIATION OF THE HUMERAL INSERT FROM THE HUMERAL 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. THE IMPLANTS WILL NOT BE RETURNED FOR INVESTIGATION AS THE IMPLANTS WERE DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SHOULDER ARTHROPLASTY AND APPROXIMATELY 08 MONTHS LATER WAS REVISED DUE TO DISSOCIATION OF THE HUMERAL INSERT FROM THE HUMERAL 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. 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
    132068 ARCHER R1 REVERSE SHOULDER SYSTEM SHOULDER PROSTHESIS PHX CATALYST ORTHOSCIENCE INC 1230-7505-002 2105622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 1230-7505-002, LOT # UNKNOWN| 1230-7505-002, LOT #2105622