BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21709024 · Received March 27, 2025

    Report

    Report Number
    3005180920-2025-00251
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    March 4, 2025
    Report Date
    March 27, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706230
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14-03-2025: LOT 2203294: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-04-2022. EXPIRATION DATE: 2027-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: LOT 2003790A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-01-2021. EXPIRATION DATE: 2026-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD (1 AS LOT 2003790B) WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE SIMILAR EVENT OCCURRED ON THIS LOT INVOLVED THIS SAME DEVICE, PATIENT EXPERIENCED LUXATION BUT THE GLENOSPHERE WAS NOT REVISED (MDR 2025-00219). 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

    ON THE (B)(6) 2025 THE PATIENT UNDERGONE REVERSE SHOULDER ARTHROPLASTY. ON THE (B)(6) 2025 THE PATIENT UNDERGONE REVISION SURGERY DUE TO JOINT LUXATION, LINER, DIAPHYSIS AND METAPHYSIS REVISED. ON THE (B)(6) 2025 THE PATIENT UNDERGONE A SECOND REVISION SURGERY DUE TO JOINT LUXATION, LINER, METAPHYSIS AND GLENOSPHERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659392 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM PHX MEDACTA INTERNATIONAL SA 04.01.0116 2203294 07630040706230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention