BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0

    MDR report key: 12560079 · Received October 1, 2021

    Report

    Report Number
    3005180920-2021-00784
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    September 2, 2021
    Report Date
    October 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 SEPTEMBER 2021: LOT 1910964: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2020. EXPIRATION DATE: 2025-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 14 SEPTEMBER 2021: REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM (K170452) LOT 183530: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2018. EXPIRATION DATE: 2023-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY AND LOOSENESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND METAPHYSIS 2 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459045 REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0 HUMERAL REVERSE METAPHYSIS PHX MEDACTA INTERNATIONAL SA 04.01.0110 1910964 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention