BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+6MM

    MDR report key: 15779261 · Received November 11, 2022

    Report

    Report Number
    3005180920-2022-00857
    Event Type
    Injury
    Date Received
    November 11, 2022
    Date of Event
    October 25, 2022
    Report Date
    November 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706254
    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 (B)(6) 2022. LOT 173416: 78 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: 2022-06-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 32 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH THREE OTHER SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2022 ON REVERSE SHOULDER SYSTEM 04.01.0206 LAT. GLENOSPHERE 32XØ24.5 (K193175) LOT. 1811033A LOT 1811033: 4 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-01-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED AT ABOUT 8 MONTHS AFTER THE PRIMARY DUE TO JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE METAPHYSIS AND THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284909 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+6MM SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0118 173416 07630040706254

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention