BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R1 REVERSE SHOULDER SYSTEM

    MDR report key: 22037538 · Received May 16, 2025

    Report

    Report Number
    3012552981-2024-00068
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    April 10, 2025
    Report Date
    May 2, 2025
    Manufacturer
    CATALYST ORTHOSCIENCE INC.
    Product Code
    PHX
    PMA / PMN Number
    K211991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WAS IMPLANTED FOR APPROXIMATELY 16 MONTHS. THE SURGEON NOTED THE PATIENT WAS REACHING BACK AND PLANTED HIS ARM THEN HEARD A POP AND FELT PAIN, THE PATIENT THEN WENT INTO THE DR. (B)(6). WITHIN WEEKS, THE SURGEON CONDUCTED THE REVISION SURGERY. DURING SURGERY IT WAS CONFIRMED THAT THE POLY DID DISASSOCIATE FROM THE STEM. TIM NOTED THAT DURING THE INITIAL SURGERY, THE SURGEON USED A SC POLY (32 +4), ASSEMBLED ON THE BACK TABLE, AND CHECKED THOROUGHLY FOR FIT (BY CONFIRMING A TIGHT FIT BY ATTEMPTING TO TWIST/PULL ON POLY) AS HE HABITUALLY DOES. THE SURGEON CONFIRMED THERE WERE NO COMPLICATIONS OR SIGNS THAT THE PATIENT WAS NONCOMPLIANT WITH RECOVERY INSTRUCTIONS DURING THE RECOVERY PERIOD. DURING THE REVISION SURGERY, DR. (B)(6) ADDED A HUMERAL SPACER +8 MM AND A RING LOCK SC POLY INSERT.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO POLY DISASSOCIATION FROM INITIAL SURGERY IN (B)(6) 2023. THE PATIENT STRETCHED BACK HIS/HER ARM AND PLANTED IT THEN HEARD A POP AND EXPERIENCED PAIN. THE SURGEON CONFIRMED THE POLY HAD DISASSOCIATED FROM THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896135 R1 REVERSE SHOULDER SYSTEM shoulder prosthesis, reverse configuration PHX CATALYST ORTHOSCIENCE INC. 1230-7517-002 237096

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention