BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MSS - HUMERAL REVERSE LINERS

    MDR report key: 24376302 · Received February 18, 2026

    Report

    Report Number
    3005180920-2026-00095
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 19, 2026
    Report Date
    February 18, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630542751073
    PMA / PMN Number
    K250338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 FEBRUARY 2026. REVERSE SHOULDER SYSTEM 04.01.0510 HUM. REV. CONSTRAINED E-CROSS LINER D 32/+6 (K250338) LOT 2503936: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2025. EXPIRATION DATE: 09-MAR-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0206 LAT. GLENOSPHERE 32XD 24.5 (K193175) LOT 2430417: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-APR-2025. EXPIRATION DATE: 17-MAR-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: DISLOCATION IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A SHOULDER SURGERY WAS PERFORMED. APPROXIMATELY (B)(6) MONTHS AFTER THE PRIMARY, THE PATIENT PRESENTED WITH PAIN ASSOCIATED WITH RECURRENT DISLOCATION OF THE GLENOSPHERE AND LINER; THE CAUSE IS UNKNOWN. PREVIOUS EPISODES WERE MANAGED WITH CLOSED REDUCTION. THE SURGEON REVISED THE LINER WITH A CONSTRAINED LINER OF THE SAME SIZE TO ADDRESS THE DISLOCATIONS. THE SURGERY WAS COMPLETED SUCCESSFULLY. AT ABOUT (B)(6) MONTH AFTER THE FIRST REVISION SURGERY, THE PATIENT AGAIN PRESENTED WITH PAIN DUE TO MULTIPLE DISLOCATIONS OF THE LINER FROM THE GLENOSPHERE. PREVIOUS EPISODES HAD BEEN MANAGED WITH CLOSED REDUCTION. THE SURGEON REVISED THE BASEPLATE AND UPSIZED BOTH THE LINER AND THE GLENOSPHERE TO ADDRESS THE DISLOCATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439504 MSS - HUMERAL REVERSE LINERS HUM. REV. CONSTRAINED E-CROSS LINER Ø32/+6 PHX MEDACTA INTERNATIONAL SA 04.01.0510 2503936 07630542751073

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention