BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22087863 · Received May 27, 2025

    Report

    Report Number
    3005180920-2025-00498
    Event Type
    Injury
    Date Received
    May 27, 2025
    Date of Event
    April 28, 2025
    Report Date
    May 27, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    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 13-05-2025: LOT 2318252A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-12-2023 EXPIRATION DATE: 2028-11-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVIES INVOLVED. BATCH REVIEW PERFORMED ON 13-05-2025: REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT 2312761: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-08-2023 EXPIRATION DATE: 2028-07-25. 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 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30 (K171058) LOT 2310105: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-09-2023 EXPIRATION DATE: 2028-09-06. 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 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 (K193175) LOT 2318703: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-12-2023 EXPIRATION DATE: 2028-11-21. 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 04.01.0187 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 14 (K180089) LOT 2103583: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-05-2021 EXPIRATION DATE: 2026-04-22. 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. 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

    THE PATIENT HAD A PRIMARY SHOULDER SURGEON ON (B)(6) 2023. ON (B)(6) 2024 THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN ROTATOR CUFF THAT WAS CAUSED FROM FALLING. THE SURGEON CONVERTED THE PATIENT FROM ANATOMIC TO REVERSE. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT (B)(4) WAS FILED. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333819 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2318252A 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention