BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM

    MDR report key: 16291932 · Received February 3, 2023

    Report

    Report Number
    3005180920-2023-00038
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    January 11, 2023
    Report Date
    February 3, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706285
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 JANUARY 2023: LOT 2114977: 26 ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2022. EXPIRATION DATE: 2027-01-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 18 JANUARY 2023 REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT 2201468: 41 ITEMS MANUFACTURED AND RELEASED ON 02-JUNE-2022. EXPIRATION DATE: 2027-05-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 33 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0008 STD HUMERAL DIAPHYSIS - CEMENTLESS - 13 (K170452) LOT 2105842: 20 ITEMS MANUFACTURED AND RELEASED ON 07-JULY-2021. EXPIRATION DATE: 2026-05-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY, STEM, AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846568 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0121 2114977 07630040706285

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention