BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM

    MDR report key: 16761530 · Received April 18, 2023

    Report

    Report Number
    3005180920-2023-00283
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    March 21, 2023
    Report Date
    April 18, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    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 (B)(6) 2023. LOT 2103242: 135 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-05-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 124 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° LOT. 2003851: 152 ITEMS MANUFACTURED AND RELEASED ON 08-APR-2021. EXPIRATION DATE: 2026-03-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 145 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN ROTATOR CUFF. THE SURGEON CONVERTED SUCCESSFULLY THE PATIENT FROM TSA TO RSA. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED COMPETITOR PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562159 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM SHOULDER REVERSE LINER PHX MEDACTA INTERNATIONAL SA 04.01.0123 2103242 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention