BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

    MDR report key: 18040569 · Received October 31, 2023

    Report

    Report Number
    3005180920-2023-00845
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    October 9, 2023
    Report Date
    October 31, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    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 10 OCTOBER 2023. LOT 2113346: 71 ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2021. EXPIRATION DATE: 2026-11-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 70 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON (B)(6) 2023 REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 (K170452) LOT. 2103876: 39 ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2021. EXPIRATION DATE: 2026-06-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 35 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO OTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 1 YEAR AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129564 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM SHOULDER REVERSE LINER PHX MEDACTA INTERNATIONAL SA 2113346 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention