BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5

    MDR report key: 17918325 · Received October 12, 2023

    Report

    Report Number
    3005180920-2023-00765
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    September 12, 2023
    Report Date
    October 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728072
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023: LOT 2247046: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2023. EXPIRATION DATE: 2028-02-05. 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 DEVICE INVOLVED BATCH REVIEW PERFORMED ON (B)(6) 2023: REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT 2211667: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEPT-2022. EXPIRATION DATE: 2027-08-16. 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

    AT 1 MONTH AND A HALF 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
    1284557 REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5 SHOULDER REVERESE GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 2247046 07630040728072

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention