BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHER R1 REVERSE SHOULDER SYSTEM

    MDR report key: 14074936 · Received April 11, 2022

    Report

    Report Number
    3012552981-2022-00012
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 11, 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 36 +8, 1230-7504-003, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CLAIMED TO HAVE BEEN SLEEPING ON THEIR SIDE ALL NIGHT AND WOKE UP WITH THEIR SHOULDER FEELING DISLOCATED. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE THE HUMERAL INSERT AND HUMERAL STEM WITH ANOTHER MANUFACTURER'S DEVICE APPROXIMATELY 02 MONTHS 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
    1441270 ARCHER R1 REVERSE SHOULDER SYSTEM SHOULDER PROSTHESIS PHX CATALYST ORTHOSCIENCE INC 1230-7504-003 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 1230-7504-003, LOT # UNKNOWN