BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER Ø36/+6MM

    MDR report key: 15770502 · Received November 10, 2022

    Report

    Report Number
    3005180920-2022-00830
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    October 14, 2022
    Report Date
    November 10, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706285
    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 17-OCT-2022 LOT 179118: (B)(4). EXPIRATION DATE: 2023-MAR-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 10-NOV-2022. REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT 2008828A: (B)(4). EXPIRATION DATE: 2026-07-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059070 REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER Ø36/+6MM SHOULDER HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0121 179118 07630040706285

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention