BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

    MDR report key: 14485910 · Received May 24, 2022

    Report

    Report Number
    3005180920-2022-00403
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 29, 2022
    Report Date
    May 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 MAY 2022: LOT 2103240: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JUNE-2021. EXPIRATION DATE: 2026-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE RECEIVED. BATCH REVIEW PERFORMED ON 02 MAY 2022: REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE 39XØ24.5 (K170452) LOT 2004022: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APRIL-2021. EXPIRATION DATE: 2026-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488261 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM SHOULDER HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 04.01.0122 2103240 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention