BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27

    MDR report key: 9792901 · Received March 5, 2020

    Report

    Report Number
    3005180920-2020-00120
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    February 4, 2020
    Report Date
    April 29, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706605
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON THE 30TH OF MARCH 2020, CLINICAL EVALUATION HAS BEEN PERFORMED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR FEW WEEKS AFTER PRIMARY RSA ANTERIOR DISLOCATION OCCURRED. THE SURGEON EXCHANGED THE REVERSE LINER WITH A THICKER ONE TO INCREASE SOFT TISSUE TENSION. THIS SORT OF EVENTS IS COMMON AND DESCRIBED IN LITERATURE AND IT IS NOT DUE TO A FAULTY DEVICE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 FEBRUARY 2020: LOT 1905788: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-OCT-2019. EXPIRATION DATE: 2024-10-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT. 1903893. BATCH REVIEW PERFORMED ON 05 MARCH 2020: LOT 1903893: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-06-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 1.5 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257261 REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27 REVERSE SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0173 1905788 07630040706605

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention