BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM

    MDR report key: 14268959 · Received May 3, 2022

    Report

    Report Number
    3005180920-2022-00330
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 2, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706322
    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 29-APR-2022. LOT 2103937: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUN-2021. EXPIRATION DATE: 2026-05-24. 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 IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0209 LAT. GLENOSPHERE 42XØ24.5 (K193175) LOT. 2103688. BATCH REVIEW PERFORMED ON 29-APR-2022. LOT 2103688: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-05-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. AT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217019 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM REVERSE SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0125 2103937 07630040706322

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention