BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM

    MDR report key: 16384607 · Received February 16, 2023

    Report

    Report Number
    3005180920-2023-00085
    Event Type
    Injury
    Date Received
    February 16, 2023
    Date of Event
    January 28, 2023
    Report Date
    February 16, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31-JAN-2023 LOT 1910876: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2020. EXPIRATION DATE: 2025-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. NOTE: GLENOSPHERE NOT REPORTED BECAUSE THE GLENOSPHERE WAS FROM COMPETITOR

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT WAS REVISED DUE TO THREADED GLENOID BASEPLATE MOBILIZATION. THE SURGEON EXPLANTED THE BASEPLATE, SCREWS, GLENOSPHERE, PE LINER AND HUMERAL METAPHYSIS AND IMPLANTED TORNIER REVISION GLENOID IMPLANTS AND REPLACED SUCCESSFULLY THE MEDACTA REVERSE METAPHYSIS AND LINER. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE METAPHYSIS AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390261 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM SHOULDER HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 04.01.0123 1910876 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention