BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21418872 · Received February 20, 2025

    Report

    Report Number
    3005180920-2025-00108
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    January 29, 2025
    Report Date
    February 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 5 FEBRUARY 2025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27/09/2024. EXPIRATION DATE: 09/09/2029. 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. ADDITIONAL IMPLANTS INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE - Ø36X27 (K170452) LOT. 2402693 BATCH REVIEW PERFORMED ON 5 FEBRUARY 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17/05/2024. EXPIRATION DATE: 01/05/2029. 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 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT. 2413111 BATCH REVIEW PERFORMED ON 5 FEBRUARY 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18/07/2024. EXPIRATION DATE: 04/07/2029. 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 04.01.0182 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K180089) LOT. 2406912. BATCH REVIEW PERFORMED ON 5 FEBRUARY 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24/04/2024. EXPIRATION DATE: 09/04/2029. 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.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED DUE TO INFECTION ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY. ALL COMPONENTS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158122 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2417925 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention