BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE 24.5X30

    MDR report key: 11043168 · Received December 20, 2020

    Report

    Report Number
    3005180920-2020-00933
    Event Type
    Injury
    Date Received
    December 20, 2020
    Date of Event
    November 24, 2020
    Report Date
    December 20, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715478
    PMA / PMN Number
    K171058
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17-DEC-2020: LOT 1811893: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2019. EXPIRATION DATE: 08-JUL-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY 2 WEEKS AFTER PRIMARY SURGERY FOR BASEPLATE MOBILIZATION FROM THE BONE. THE PATIENT HAS DEMENTIA. ALL COMPONENTS HAVE BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508461 REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE 24.5X30 SHOULDER THREADED GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0191 07630040715478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention