BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYST ORTHOSCIENCE R1 REVERSE SHOULDER SYSTEM

    MDR report key: 21676977 · Received March 24, 2025

    Report

    Report Number
    MW5168014
    Event Type
    Injury
    Date Received
    March 24, 2025
    Report Date
    March 19, 2025
    Manufacturer
    CATALYST ORTHOSCIENCE INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A TOTAL SHOULDER SYSTEM (SEE ABOVE) DONE BY DR. (B)(6) IN (B)(6) OF 2023. I HAD NO PHYSICAL ISSUES AND HAD PT. I RETURNED IN EARLY (B)(6) OF THAT YEAR AND WAS RELEASED FROM CARE. SHORTLY AFTERWARDS, I COULD FEEL A (BOLT) SCREW IN MY UPPER ARM. I RETURNED TO DR. (B)(6) AND THE BOLT THAT HELD THE GLENOID ON THE BASE PLATE WAS DOWN IN MY ARM. I ASKED HIM HOW THIS HAPPENED AND HE SAID IT SHOULD NOT HAVE. HE TOLD ME THAT I HAD THE FIRST 8+ REPLACEMENT IN THE US. NOW I GUESS I HAD THE FIRST FAILURE. FAST FORWARD TO (B)(6) AND THE SECOND ASSEMBLY STARTED DISLOCATING. I WAS ABLE TO MANIPULATE IT BACK INTO PLACE. (B)(6), I RETURNED TO DR. (B)(6) AND I WAS PUT INTO AN IMMOBILIZED SLING FOR 6 WEEKS 24/7. STILL KEPT DISLOCATING. ANOTHER SURGERY IN (B)(6) AND ANOTHER OPERATION AND PARTS REPLACEMENT. OBVIOUSLY, THIS IS NOT OKAY. I HAVE NOT BEEN ABLE TO REGAIN MY RANGE OF MOTION AND I DON¿T WANT ANYONE ELSE TO GO THROUGH THE TRAUMA THAT I HAVE EXPERIENCED. I TRULY BELIEVE THAT THIS IS A PROSTHETIC FAILURE AND I AM SURPRISED THAT I HAVE NOT SEEN ANY REPORTS OF THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100259 CATALYST ORTHOSCIENCE R1 REVERSE SHOULDER SYSTEM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX CATALYST ORTHOSCIENCE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown