BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22011826 · Received May 13, 2025

    Report

    Report Number
    3005180920-2025-00417
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 19, 2025
    Report Date
    May 13, 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 24 APR 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2024. EXPIRATION DATE: 2029-08-05. 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: 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. ADDITIONAL INVOLVED DEVICES: REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM (K170452) LOT. 2416294 BATCH REVIEW PERFORMED ON 24 APR 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-AUG-2024. EXPIRATION DATE: 2029-08-05. 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 04.01.0170 GLENOSPHERE - Ø39X24.5 (K170452) LOT. 2421292 BATCH REVIEW PERFORMED ON 24 APR 2025 B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2024. EXPIRATION DATE: 2029-11-07. 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 - Ø24.5X20 - FULL WEDGE 20° (K231911) LOT. 2315757 BATCH REVIEW PERFORMED ON 24 APR 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2024. EXPIRATION DATE: 2029-04-04. 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 04.01.0186 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 13 (K180089) LOT. 2415621 BATCH REVIEW PERFORMED ON 24 APR 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-AUG-2024. EXPIRATION DATE: 2029-07-11. 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.

    Description of Event or Problem · 0

    AT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879802 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2409949 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention