BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM

    MDR report key: 20117927 · Received September 2, 2024

    Report

    Report Number
    3005180920-2024-00678
    Event Type
    Injury
    Date Received
    September 2, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08-AUG-2024: LOT 2302982: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2023. EXPIRATION DATE: 2028-05-14. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 08-AUG-2024: LOT 2302405: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2023. EXPIRATION DATE: 2028-05-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW, BUT ON THE SAME LINER THAT NOT WAS REVISED IN THE PRECEDENT REVISION SURGERY ON THIS SAME PATIENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED SUCCESSFULLY THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055683 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 2302982 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention