BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10

    MDR report key: 19018506 · Received April 2, 2024

    Report

    Report Number
    3005180920-2024-00167
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715911
    PMA / PMN Number
    K180089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 MARCH 2024: LOT 2010429: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JAN-2021. EXPIRATION DATE: 2026-JAN-07. 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 IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 12 MARCH 2024: ANATOMICAL SHOULDER SYSTEM 04.01.0092 METAL HUMERAL HEAD Ø44 (K170910) LOT 2003857: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-DEC-2020. EXPIRATION DATE: 2025-NOV-19. 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. ANATOMICAL SHOULDER SYSTEM 04.01.0128 HC PEGGED GLENOID Ø40 (K170910) LOT 2009956: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2021. EXPIRATION DATE: 2026-JAN-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.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED AT 2 YEARS AND 2 MONTHS FROM THE PRIMARY SURGERY DUE TO DISLOCATION OF THE HUMERAL HEAD FROM THE GLENOID. INTRAOPERATIVELY, IT WAS DETERMINED THAT THE PATIENT'S HUMERUS WAS FRACTURED AND THE SURGEON OPTED TO USE A FRACTURE STEM FROM EXACTECH TO COMPLETE THE CASE. THE SURGEON CONVERTED THE PATIENT FROM AN ANATOMIC SHOULDER TO A REVERSE SHOULDER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767646 ANATOMICAL SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10 HUMERAL DIAPHYSIS PHX MEDACTA INTERNATIONAL SA 2010429 07630040715911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention