BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSS GLENOSPHERE. ECCENTRIC-S. 5MM

    MDR report key: 20397762 · Received October 8, 2024

    Report

    Report Number
    3002788818-2024-00105
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 8, 2024
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    PHX
    UDI-DI
    00885556863824
    PMA / PMN Number
    K181999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION REPORTED THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT WITHOUT EVIDENCE ABOUT A SPECIFIC PRODUCT PROBLEM. THE REPORTED COMPLICATION RELATES TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A SHOULDER SURGERY, THE RSS GLENOSPHERE. ECCENTRIC-S. 5 MM WAS LOOSE. ON (B)(6) 2024, THE PATIENT UNDERWENT A REVISION SURGERY TO EXCHANGE THE RSS GLENOSPHERE. ECCENTRIC-S. 5 MM, AND THE RSS HXL LINER STANDARD. +0S WAS EXCHANGED AS WELL. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16623 RSS GLENOSPHERE. ECCENTRIC-S. 5MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ASCENSION ORTHOPEDICS, INC. UNKNOWN 00885556863824

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention RSS HXL LINER STANDARD. +0S//LNR-0960-191-0S