BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20618943 · Received November 6, 2024

    Report

    Report Number
    3005180920-2024-00884
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 7, 2024
    Report Date
    November 6, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706285
    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 8 OCTOBER 2024. LOT 2336601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2023. EXPIRATION DATE: 2028-NOV-22. 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 IMPLANT INVOLVED; BATCH REVIEW PERFORMED ON 8 OCTOBER 2024. REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT 2342040: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2024. EXPIRATION DATE: 2029-FEB-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE 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. ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418389 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM PHX MEDACTA INTERNATIONAL SA 04.01.0121 2336601 07630040706285

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention