BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM

    MDR report key: 16385147 · Received February 16, 2023

    Report

    Report Number
    3005180920-2023-00045
    Event Type
    Injury
    Date Received
    February 16, 2023
    Date of Event
    January 17, 2023
    Report Date
    February 16, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    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 19 JANUARY 2023. LOT 2103234: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JUN-2021. EXPIRATION DATE: 2026-MAY-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. ADDITIONAL COMPONENT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27 (K170452) LOT 2201465: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2022. EXPIRATION DATE: 2027-APR-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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER AND METAPHYSIS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360219 REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM SHOULDER HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0119 2103234 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention