BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø27X30

    MDR report key: 18795671 · Received February 28, 2024

    Report

    Report Number
    3005180920-2024-00058
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    January 29, 2024
    Report Date
    February 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    PMA / PMN Number
    K171058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01-FEB-2024 LOT 183705: (B)(4) MANUFACTURED AND RELEASED ON 29-AUG-2018. EXPIRATION DATE: 2023-08-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 5 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE BASEPLATE. THE GLENOSPHERE WAS WELL FIXED IN PLACE. THE SURGEON CONVERTED THE PATIENT TO A HEMI SHOULDER SYSTEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BONE GRAFT WAS NOT USED DURING THE PRIMARY SURGERY. IT HAS BEEN REPORTED THAT THE LOOSENING OF THE IMPLANT WAS MOST LIKELY CAUSED BY THE PATIENT'S TYPE OF WORK, WHICH REQUIRES THE USE OF HIGH FORCE WITH SHOULDERS AND ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444959 REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø27X30 THREADED GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 183705

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention