BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23510653 · Received November 10, 2025

    Report

    Report Number
    3005180920-2025-01127
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 24, 2025
    Report Date
    November 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706285
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 OCTOBER 2025 REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER D 36/+6MM (K170452) LOT. 2501309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 APRIL 2025. EXPIRATION DATE: 03 APRIL 2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 27 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0278 SENSITIN LAT. GLENOSPHERE 36XD 24.5 (K203755) LOT. 2012762: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MARCH 2021. EXPIRATION DATE: 08 MARCH 2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 32 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH A SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT INITIALLY UNDERWENT PRIMARY SHOULDER SURGERY USING A COMPETITOR & RSQUO, S PRODUCTS. ON (B)(6) 2025, A REVISION WAS PERFORMED WITH MEDACTA IMPLANTS. ON (B)(6), 2025, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF UNKNOWN CAUSE. REVISION SURGERY WAS PERFORMED TO ENLARGE THE GLENOSPHERE, METAPHYSIS, AND LINER TO ENHANCE JOINT STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615170 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM PHX MEDACTA INTERNATIONAL SA 04.01.0121 2501309 07630040706285

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention