BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5

    MDR report key: 11243106 · Received January 28, 2021

    Report

    Report Number
    3005180920-2021-00075
    Event Type
    Injury
    Date Received
    January 28, 2021
    Date of Event
    December 29, 2020
    Report Date
    January 28, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 8 JANUARY 2021: LOT 1910952: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-JUN-2020. EXPIRATION DATE: 2025-05-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM (K170452) LOT. 2000922. BATCH REVIEW PERFORMED ON 8 JANUARY 2021: LOT 2000922: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2020. EXPIRATION DATE: 2025-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140742 REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5 REVERSE SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0169 1910952 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention