BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25

    MDR report key: 16349595 · Received February 10, 2023

    Report

    Report Number
    3005180920-2023-00056
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    January 12, 2023
    Report Date
    February 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040708098
    PMA / PMN Number
    K171058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01-FEB-2023. LOT 2113522: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2021. EXPIRATION DATE: 2026-11-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSITIONED BASEPLATE 5 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE BASEPLATE, POLY, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44179 REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25 SHOULDER THREADED GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0190 2113522 07630040708098

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention