BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS VAULTLOCK GLENOID, LARGE

    MDR report key: 22162004 · Received June 6, 2025

    Report

    Report Number
    1220246-2025-02417
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    April 15, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867239333
    PMA / PMN Number
    K161108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED BY THE STUDY FINDINGS PRESENTED IN THE SHOULDER ARTHROPLASTY REGISTRY CONDUCTED BY THE REGENTS OF THE UNIVERSITY OF MICHIGAN REGARDING IMPLANT REMOVAL. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT. COMPLAINT ALLEGATION IS NOT CONFIRMED BY THE STUDY FINDINGS PRESENTED IN THE SHOULDER ARTHROPLASTY REGISTRY CONDUCTED BY THE REGENTS OF THE UNIVERSITY OF MICHIGAN REGARDING IMPLANT REMOVAL. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    ON 4/15/2025, A CLINDEX NOTIFICATION WAS RECEIVED VIA EMAIL INDICATING THAT A PATIENT LISTED IN THE SHOULDER ARTHROPLASTY REGISTRY EXPERIENCED A SUBSCAPULARIS FAILURE. AS A RESULT, THE PATIENT UNDERWENT A REVISION PROCEDURE, CONVERTING TO A DIFFERENT TYPE OF ARTHROPLASTY. THE INITIAL ECLIPSE PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2024. THE EVENT WAS DETERMINED TO BE UNRELATED TO THE ORIGINAL SURGERY. ADDITIONAL INFORMATION RECEIVED ON 5/14/2025: DURING THE REVISION SURGERY ON (B)(6) 2025, AN AR-9347-18 ARTHREX ECLIPSE HUMERAL HEAD, AN AR-9301-03 ARTHREX ECLIPSE CAGE SCREW LARGE, AN AR-9301-47CPC ARTHREX ECLIPSE TRUNION, AND AN AR-9106-03 ARTHREX UNIVERS VAULTLOCK GLENOID WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603457 UNIVERS VAULTLOCK GLENOID, LARGE PROSTHESIS, SHOULDER, CEMENTED KWS ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, LARGE S81303073 00888867239333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other