BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5

    MDR report key: 10091539 · Received May 27, 2020

    Report

    Report Number
    3005180920-2020-00299
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    April 28, 2020
    Report Date
    May 27, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706575
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 27 MAY 2020: LOT 183537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2018. EXPIRATION DATE: 2023-10-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 27 MAY 2020: REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT 184048: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-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 WITHOUT ANY SIMILAR REPORTED EVENTS. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: PARTIAL REVISION OF RSA 1 YEAR AFTER PRIMARY SURGERY. ACCORDING TO REPORT THE PATIENT FELL AND THE TRAUMA CAUSED DISLOCATION OF THE GLENOSPHERE FROM THE BASEPLATE AND DAMAGE TO THE PE INSERT. THE RELATIONSHIP BETWEEN TRAUMA AND SEPARATION OF GLENOSPHERE FROM BASEPLATE IS UNCERTAIN, BUT EXPERIENCE ON THE SPECIFIC IS VERY LIMITED AND A FIRM CONCLUSION CANNOT BE DRAWN. MOST LIKELY, THE TRAUMATIC EVENT IS RESPONSIBLE FOR THE FAILURE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A FALL 1 YEAR AFTER THE PRIMARY SURGERY. THE LINER IS WORN, THE GLENOSPHERE DISSOCIATED FROM THE BASEPLATE AND THE SCREW UNSCREWED. THE SURGEON REVISED THE GLENOSPHERE, LINER, METAPHYSIS AND LEFT THE BASEPLATE IN PLACE AS IT WAS WELL FIXED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558299 REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5 SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0170 183537 07630040706575

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention