BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 24579145 · Received March 12, 2026

    Report

    Report Number
    3005180920-2026-00166
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706285
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 FEBRUARY 2026. REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER D 36/+6MM (K170452) LOT 2402704: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2024. EXPIRATION DATE: 2029-04-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 38 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XD 24.5 (K193175) LOT 2242315: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-DEC-2022. EXPIRATION DATE: 2027-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 38 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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

    AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DURING ROTATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595084 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM PHX MEDACTA INTERNATIONAL SA 04.01.0121 2402704 07630040706285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention