BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5

    MDR report key: 11654450 · Received April 13, 2021

    Report

    Report Number
    3005180920-2021-00295
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 13, 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 25 MARCH 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 WITH OTHER 2 SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT. 2004289 BATCH REVIEW PERFORMED ON 25 MARCH 2021: LOT 2004289: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JULY-2020. EXPIRATION DATE: 2025-07-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 111 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551649 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 68 YR Required Intervention