BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22961105 · Received September 4, 2025

    Report

    Report Number
    3005180920-2025-00842
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 4, 2025
    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 21 AUGUST 2025: REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT: 2245566: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-APRIL-2023. EXPIRATION DATE: 2028-03-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 21 AUGUST 2025: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT: 2242389: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MARCH-2023. EXPIRATION DATE: 2028-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 (K193175) LOT: 2247046: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2023. EXPIRATION DATE: 2028-02-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY WITH THE CAUSE UNKNOWN. THE SURGEON REVISED THE METAPHYSIS, LINER (3 TO 6 MM) AND GLENOSPHERE (39 TO 42 LAT). THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2449179 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM PHX MEDACTA INTERNATIONAL SA 04.01.0123 2245566 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Required Intervention