BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 32XØ24.5

    MDR report key: 18493518 · Received January 11, 2024

    Report

    Report Number
    3005180920-2023-01096
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    December 16, 2023
    Report Date
    January 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728058
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 JANUARY 2024. LOT 2117710: (B)(4) MANUFACTURED AND RELEASED ON 22-MARCH-2022. EXPIRATION DATE: 2027-03-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE COMPLAINT: BATCH REVIEW PERFORMED ON 09 JANUARY 2024 REVERSE SHOULDER SYSTEM 04.01.0116 HUMERAL REVERSE HC LINER Ø32/+0MM (K170452) LOT 2203294: (B)(4) MANUFACTURED AND RELEASED ON 21-APR-2022. EXPIRATION DATE: 2027-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667072 REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 32XØ24.5 REVERSE SHOULDER GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 2117710 07630040728058

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention