BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM

    MDR report key: 18517260 · Received January 16, 2024

    Report

    Report Number
    3005180920-2023-01113
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    December 26, 2023
    Report Date
    January 16, 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 02 JANUARY 2024: LOT 2207933: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2022. EXPIRATION DATE: 2027-05-16. 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, BATCH REVIEW PERFORMED ON 02 JANUARY 2024:: REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT. 2247045. LOT 2247045: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-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 WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR SHOULDER SUB-LUXATION 5 MONTHS POST PRIMARY. LINER, GLENOSPHERE AND METAPHYSIS REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759374 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 2207933 07630040706285

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention