BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 24871722 · Received April 14, 2026

    Report

    Report Number
    3005180920-2026-00318
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 14, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 MARCH 2026: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER D 39/+0MM (K170452) LOT: 2505029: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2025. EXPIRATION DATE: 2030-MAY-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE - D 39X24.5 (K170452) LOT: 2518003: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-OCT-2025. EXPIRATION DATE: 2030-OCT-01. 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. REVERSE SHOULDER SYSTEM 04.01.0402 GRS BASEPLATE - D 24.5X20 - FULL WEDGE 20° (K231911) LOT: 2339044: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2025. EXPIRATION DATE: 2030-JAN-27. 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. 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

    THE PATIENT HAD A SHOULDER INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND DEBRIDEMENT. THE SURGEON ALSO REVISED THE D 39 LINER TO A SAME SIZE LINER AND REVISED THE D 39X24.5 GLENOSPHERE TO A SAME SIZE GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371031 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM PHX MEDACTA INTERNATIONAL SA 04.01.0122 2505029 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention