BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20485245 · Received October 18, 2024

    Report

    Report Number
    3005180920-2024-00822
    Event Type
    Injury
    Date Received
    October 18, 2024
    Date of Event
    September 20, 2024
    Report Date
    October 18, 2024
    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 23-SEPT-2024. LOT 2311719: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-AUG-2023. EXPIRATION DATE: 2028-08-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 41 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ27 (K193175) LOT 2318705: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2023. EXPIRATION DATE: 2028-11-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE GLENOSPHERE, LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219036 SHOULDER SYSTEM SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0123 2311719 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention