BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20256798 · Received September 19, 2024

    Report

    Report Number
    3005180920-2024-00766
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    February 10, 2025
    Report Date
    March 5, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706315
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MODIFICATIONS/ADDITIONAL INFORMATION REPORTED HAVE BEEN RECOGNIZED DURING THE CHECK OF A COMPLAINT ON THE SAME PATIENT INVOLVED IN THIS CASE AND REPORTED PER MDR 005180920-2025-00052. ADDITIONAL INFORMATION: INVOLVED LINER: BATCH REVIEW PERFORMED ON 17 FEBRURAY 2025: LOT: 2400595: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2024. EXPIRATION DATE: 2029-04-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CORRECTIONS: THE LINER LOT: 2335876 REPORTED IN THE INITIAL MDR: (B)(4) WAS NOT PART OF THIS COMPLAINT. DEVICES IMPLANTED ON (B)(6) 2024 (6.A.).

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2024. LOT 2335876: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-DEC-2023. EXPIRATION DATE: 2028-11-15. 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. ADDIITONAL IMPLANT INVOLVED. REVERSE SHOULDER SYSTEM 04.01.0279 SENSITIN LAT. GLENOSPHERE 39XØ24.5 (K203755) LOT 2302405: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2023. EXPIRATION DATE: 2028-05-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO OTHER SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. ON (B)(6) 2024, 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. ON (B)(6) 2024, 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. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    AT ABOUT 3 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 AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747423 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM PHX MEDACTA INTERNATIONAL SA 04.01.0124 2400595 07630040706315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention