BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17755250 · Received September 15, 2023

    Report

    Report Number
    3005180920-2023-00697
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    August 17, 2023
    Report Date
    September 15, 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 21-AUG-2023. LOT 2243887: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2023. EXPIRATION DATE: 2028-01-22. 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 INVOLVED IMPLANT: BATCH REVIEW PERFORMED ON 11-SEPT-2023 ON REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT. 2303943 LOT 2303943: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2023. EXPIRATION DATE: 2028-04-01. 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.

    Description of Event or Problem · 0

    AT 3 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM 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
    315224 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM REVERSE SHOULDER SYSTEM HUMERAL HIGH CROSS LINER PHX MEDACTA INTERNATIONAL SA 2243887 07630040706278

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Required Intervention