BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM

    MDR report key: 17069846 · Received June 6, 2023

    Report

    Report Number
    3005180920-2023-00401
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    May 11, 2023
    Report Date
    June 6, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706278
    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 (B)(6) 2023: LOT 2212973: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SET-2022. EXPIRATION DATE: 2027-08-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 (K170452) LOT. 2240329: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2023. EXPIRATION DATE: 2027-12-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION FOR SHOULDER LUXATION 1 MONTH AFTER PRIMARY. REVERSE SHOULDER GLENOSPHERE AND LINER WERE REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189353 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM SHOULDER HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 04.01.0120 2212973 07630040706278

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention