BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24788894 · Received April 6, 2026

    Report

    Report Number
    1220246-2026-01918
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    July 1, 2022
    Report Date
    April 6, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 10-MAR-2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN 2022 BY THE JOURNAL OF SHOULDER AND ELBOW SURGERY, TITLED ¿THE RECOVERY CURVE OF ANATOMIC TOTAL SHOULDER ARTHROPLASTY FOR PRIMARY GLENOHUMERAL OSTEOARTHRITIS: MIDTERM RESULTS AT A MINIMUM OF 5 YEARS ". THE STUDY REVIEWED EIGHTY-ONE (81) PATIENTS WHO UNDERWENT ANATOMIC TOTAL SHOULDER ARTHROPLASTY (ATSA), USING UNIVERS II (ARTHREX) AND UNIVERS VAULTLOCK (ARTHREX), TO ADDRESS PRIMARY GLENOHUMERAL OSTEOARTHRITIS. DURING THE SIXTY (60) MONTH FOLLOW-UP PERIOD, ONE (1) PATIENT EXPERIENCED CHRONIS INSTABILITY LEADING TO REVISION. SOURCE: ALTINTAS, BURAK, ET AL. "THE RECOVERY CURVE OF ANATOMIC TOTAL SHOULDER ARTHROPLASTY FOR PRIMARY GLENOHUMERAL OSTEOARTHRITIS: MIDTERM RESULTS AT A MINIMUM OF 5 YEARS." JSES INTERNATIONAL 6.4 (2022): 587-595.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99604 UNK PROSTHESIS, SHOULDER, CEMENTED KWS ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other