BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22911360 · Received August 28, 2025

    Report

    Report Number
    3005180920-2025-00821
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 6, 2025
    Report Date
    August 28, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2025 REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT. 2335056: 45 ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2023. EXPIRATION DATE: 20-NOV-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 39 ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES ALSO REVISED: REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 (K193175) LOT. 2240583: 20 ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2022. EXPIRATION DATE: 17-NOV-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE 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

    REVISION SURGERY PERFORMED AT 10 MONTHS DUE TO JOINT LUXATION; THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. METAPHYSIS WAS REVISED TO GIVE THE PATIENT MORE VERSION SO IT WOULD BE DIFFICULT TO DISLOCATE IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519307 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM PHX MEDACTA INTERNATIONAL SA 04.01.0123 2335056 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention