BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CENTRAL SCREW

    MDR report key: 25278231 · Received May 26, 2026

    Report

    Report Number
    0001649390-2026-00492
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    June 1, 2020
    Report Date
    May 26, 2026
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    "THE MANUFACTURER RECEIVED CLINICAL STUDY NAMED ""A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF SHOULDER JOINT REPLACEMENT WITH THE AEQUALIS ASCEND FLEX SHOULDER SYSTEM"" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF AEQUALIS ASCEND FLEX SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES BETWEEN 30TH JANUARY 2013 ¿ 1ST JUNE 2020. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: A 63-YEAR-OLD MALE WHO UNDERWENT LEFT REVERSE SHOULDER ARTHROPLASTY FOR SEVERE OA AS THE INDEX PROCEDURE. HE HAD REVISION FOR LOOSENING OF THE GLENOID BASEPLATE AND CENTRAL SCREW FAILURE FOLLOWING A TRAUMATIC INJURY. AT THE TIME OF REVISION, THE HUMERAL STEM WAS WELL FIXED AND GLENOID COMPONENT UNDERWENT A SINGLE STAGE REVISION WITH BONE GRAFTING. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26744 UNK CENTRAL SCREW PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED KWS TORNIER INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1