BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHER R1 REVERSE SHOULDER SYSTEM

    MDR report key: 13722157 · Received March 10, 2022

    Report

    Report Number
    3012552981-2022-00001
    Event Type
    Injury
    Date Received
    March 10, 2022
    Date of Event
    December 21, 2021
    Report Date
    February 22, 2022
    Manufacturer
    CATALYST ORTHOSCIENCE INC
    Product Code
    PHX
    UDI-DI
    00811596030476
    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 36 +12, 1230-7504-004, LOT # 2105618. 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 WAS EXPERIENCING CHRONIC INSTABILITY IN THEIR SHOULDER. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE THE HUMERAL INSERT AND HUMERAL STEM WITH ANOTHER MANUFACTURER'S DEVICE THAT PROVIDED ADDITIONAL HEIGHT OFFSET AND CONSTRAINT APPROXIMATELY 01 MONTH AFTER THE PREVIOUS SURGERY. THE HUMERAL INSERT WAS FOUND TO BE DISSOCIATED FROM THE HUMERAL STEM. 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
    1622859 ARCHER R1 REVERSE SHOULDER SYSTEM SHOULDER PROSTHESIS PHX CATALYST ORTHOSCIENCE INC 1230-7504-004 2105618 00811596030476

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 1230-7504-004, LOT # 2105618