BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18236216 · Received November 30, 2023

    Report

    Report Number
    3005180920-2023-00910
    Event Type
    Injury
    Date Received
    November 30, 2023
    Date of Event
    November 1, 2023
    Report Date
    November 30, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    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 03 NOVEMBER 2023. LOT 2245565: 45 ITEMS MANUFACTURED AND RELEASED ON 13-APR-2023. EXPIRATION DATE: 2028-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 37 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED (NOT REVISED): REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 (K193175) LOT 2247046: 50 ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2023. EXPIRATION DATE: 2028-02-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 24 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH OTHER 3 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180225 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM REVERSE HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 2245565 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention