BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM

    MDR report key: 9706057 · Received February 13, 2020

    Report

    Report Number
    3005180920-2020-00047
    Event Type
    Injury
    Date Received
    February 13, 2020
    Date of Event
    January 14, 2020
    Report Date
    February 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706315
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13-FEB-2020: 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 WITH 1 OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: REVIEW FOR REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39X24.5 (NOT DISTRIBUTED IN USA) LOT. 189936. BATCH REVIEW PERFORMED ON 13-FEB-2020: LOT 189936: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2019. EXPIRATION DATE: 17.02.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO SHOULDER INSTABILITY, AN ANATOMIC PROSTHESIS HAS BEEN USED TO REPLACE REVERSE DEVICES. THE PATIENT WAS ALREADY REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171570 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM REVERSE SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0124 183530 07630040706315

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention