BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHER R1 REVERSE SHOULDER SYSTEM

    MDR report key: 19354755 · Received May 20, 2024

    Report

    Report Number
    3012552981-2024-00075
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    May 8, 2024
    Report Date
    May 20, 2024
    Manufacturer
    CATALYST ORTHOSCIENCE INC.
    Product Code
    PHX
    UDI-DI
    00811596030452
    PMA / PMN Number
    202611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DHR FOR THE POLYETHYLENE INSERT WAS REVIEWED AND, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NON-CONFORMITIES ASSOCIATED WITH THE COMPONENT THAT MAY HAVE CONTRIBUTED TO THE EVENT IDENTIFIED DURING MANUFACTURING. THE DEVICES WAS VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WAS WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. THE RETURNED POLY INSERT WAS EVALUATED AND FOUND NICKED, DEFORMED, AND SCRATCHED. IT IS NOT KNOWN WHEN THE DEFORMATION OF THE POLY INSERT TOOK PLACE AND LIKELY OCCURRED AFTER DISSOCIATION OR DURING EXPLANATION. CATALYST HAS IDENTIFIED TWO FACTORS THAR COULD CONTRIBUTE TO DISSOCIATION. ONE FACTOR IS NOT FOLLOWING THE SURGICAL TECHNIQUE AND NOT ASSEMBLING THE POLY INSERT COMPLETELY WITHIN THE HUMERAL STEM. THE OTHER FACTOR IS THE POLY INSERT EXPERIENCING A HIGH FORCE NOT IN-LINE WITH THE INSERT / STEM INTERFACE.

    Description of Event or Problem · 0

    INITIAL SURGERY WAS PERFORMED ON (B)(6) 2023. DEVICE HAD BEEN IMPLANTED FOR APPROXIMATELY 1 YEAR 3 MONTHS. PATIENT REPORTED A FALL WHILE WALKING DOG TO SURGEON WHEN BEING EVALUATED FOR POSSIBLE DISLOCATION. FOLLOWING REVISION, IT WAS REPORTED THAT THE POLY INSERT HAD DISSOCIATED FROM THE HUMERAL STEM. REVISION SURGEON REMOVED POLY INSERT 36MM +4 P/N 1230-7504-002 AND IMPLANTED NEW POLY INSERT 36MM + 0 P/N 1230-7518-001, HUMERAL SPACER +8MM P/N 1230-7522-001, AND SPACER LOCKING SCREW P/N 1230-7521-001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788515 ARCHER R1 REVERSE SHOULDER SYSTEM SHOULDER PROSTHESIS PHX CATALYST ORTHOSCIENCE INC. 1230-7504-002 211071 00811596030452

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention 1230-7504-002, LOT # 211071