BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21290771 · Received February 3, 2025

    Report

    Report Number
    3005180920-2025-00020
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 11, 2025
    Report Date
    February 3, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    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 16-01-2024: LOT 2306774: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-07-2023. EXPIRATION DATE: 2027-06-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 16-01-2024: REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE - Ø39X27 (K170452) LOT 2201466: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-05-2022. EXPIRATION DATE: 2027-05-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS FROM PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166261 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM PHX MEDACTA INTERNATIONAL SA 04.01.0122 2306774 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention