BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 24004369 · Received January 8, 2026

    Report

    Report Number
    3005180920-2026-00018
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    December 22, 2025
    Report Date
    January 8, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040708098
    PMA / PMN Number
    K171058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 DEC 2025. LOT 2110370: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 NOV 2021. EXPIRATION DATE: 02 NOV 2026. 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. 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

    REVISION SURGERY AFTER 3 YEARS AND 10 MONTHS POST-PRIMARY DUE TO A LOOSE BASEPLATE. ALL COMPONENTS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67878 SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25 PHX MEDACTA INTERNATIONAL SA 04.01.0190 2110370 07630040708098

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention