BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM

    MDR report key: 14675294 · Received June 13, 2022

    Report

    Report Number
    3005180920-2022-00447
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 13, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706339
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 MAY 2022. LOT 2006597: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2022. EXPIRATION DATE: 2025-11-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. ADDITIONAL COMPONENT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0209 LAT. GLENOSPHERE 42XØ24.5 (K193175) LOT. 2103688: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-05-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. A PREVIOUS CASE ON THE SAME LOT WAS REPORTED DUE TO JOINT INSTABILITY.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY SHOULDER SURGERY ON 7 MARCH 2022. ON 6 APRIL 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS AND LINER. PRESENTLY, ON 16 MAY 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO DISLOCATION AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS EXCEPT FOR THE STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON CONVERTED THE PATIENT TO A HEMIARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965953 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM SHOULDER REVERSE LINER PE PHX MEDACTA INTERNATIONAL SA 04.01.0126 2006597 07630040706339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention