BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30

    MDR report key: 16520983 · Received March 10, 2023

    Report

    Report Number
    3005180920-2023-00136
    Event Type
    Injury
    Date Received
    March 10, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715478
    PMA / PMN Number
    K171058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 FEBRUARY 2023: LOT 2113523: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2022. EXPIRATION DATE: 2027-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4)ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSITIONED BASEPLATE AND THE CAUSE OF THE MALPOSITIONED BASEPLATE IS UNKNOWN. AT ABOUT 8 MONTHS FROM PRIMARY SURGERY, THE SURGEON REVISED THE BASEPLATE, GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196274 REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30 SHOULDER GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0191 2113523 07630040715478

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention