BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23231346 · Received October 7, 2025

    Report

    Report Number
    3005180920-2025-00939
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 7, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    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 24 SEPTEMBER 2025: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2413114: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SETT-2024. EXPIRATION DATE: 01-SETT-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED, BATCH REVIEW PERFORMED ON 24 SEPTEMBER 2025: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT. 2409942: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUNE-2024. EXPIRATION DATE: 30-MAY-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0301 GRS BASEPLATE - Ø24.5X20 +3MM (K213459) LOT. 2408053: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JULY-2024. EXPIRATION DATE: 20-JUNE-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT 5 MONTHS AFTER THE PRIMARY PROCEDURE, THE PATIENT PRESENTED WITH AN INFECTION OF UNKNOWN CAUSE. THE SURGEON REVISED THE SHOULDER FROM A REVERSE SYSTEM TO A HEMIARTHROPLASTY. THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746251 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2413114

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention