BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ27

    MDR report key: 19850278 · Received July 29, 2024

    Report

    Report Number
    3005180920-2024-00575
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    July 15, 2024
    Report Date
    July 29, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 JULY 2024 LOT 2115873: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2022. EXPIRATION DATE: 2027-03-01. 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 ITEM INVOLVED IN THE COMPLAINT, BATCH REVIEW PERFORMED ON 16 JULY 2024: REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM (K170452) LOT. 2201878 LOT 2201878: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2022. EXPIRATION DATE: 2027-03-21. 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

    REVISION SURGERY DUE TO LUXATION OF THE GLENOSPHERE FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. AT ABOUT 1 YEAR AND 8 MONTHS POST-PRIMARY THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399324 REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ27 GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 2115873

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention