BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM

    MDR report key: 9416218 · Received December 5, 2019

    Report

    Report Number
    3005180920-2019-01026
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    November 8, 2019
    Report Date
    December 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706230
    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 28 NOVEMBER 2019. LOT 173414: 80 ITEMS MANUFACTURED AND RELEASED ON 21-JUNE-2017. EXPIRATION DATE: 05.06.2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 40 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS. BATCH REVIEW PERFORMED ON 28 NOVEMBER 2019. REVERSE SHOULDER SYSTEM 04.01.0178 GLENOSPHERE 32XØ24.5 LOT. 179968 (K170452) LOT 179968: 74 ITEMS MANUFACTURED AND RELEASED ON 18-APRIL-2018. EXPIRATION DATE: 2023-04-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 30 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A SHOULDER DISLOCATION 1 MONTH AFTER PRIMARY. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NEW LINER: HUMERAL REVERSE HC LINER Ø32/+6MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209827 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM SHOULDER HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 173414 07630040706230

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention