BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHER R1 REVERSE SHOULDER SYSTEM

    MDR report key: 15685201 · Received October 27, 2022

    Report

    Report Number
    3012552981-2022-00026
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    October 19, 2022
    Report Date
    October 27, 2022
    Manufacturer
    CATALYST ORTHOSCIENCE, INC.
    Product Code
    PHX
    UDI-DI
    00811596030452
    PMA / PMN Number
    K202611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: POLY INSERT IMPLANT SIZE 36 +4, 1230-7504-002, LOT # 2105613. 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 INITIAL SHOULDER ARTHROPLASTY AND APPROXIMATELY 10 MONTHS LATER WAS REVISED DUE TO DISSOCIATION OF THE HUMERAL INSERT FROM THE HUMERAL STEM. THE PREVIOUS HUMERAL INSERT WAS REPLACED WITH A +12 SPACER AND 36+0 INSERT. THE PATIENT REPORTED AN EVENT PUSHING A SHOPPING CART 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
    2776816 ARCHER R1 REVERSE SHOULDER SYSTEM SHOULDER PROSTHESIS PHX CATALYST ORTHOSCIENCE, INC. 1230-7504-002 2105613 00811596030452

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 1230-7504-002, LOT 2105613.