BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25

    MDR report key: 18854199 · Received March 7, 2024

    Report

    Report Number
    3005180920-2024-00120
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 7, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040708098
    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 20 FEBRUARY 2024 LOT 2201532: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2022. EXPIRATION DATE: 2027-MAY-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME REPORTING PAIN. X-RAYS THAT WERE TAKEN SHOWED THAT THE ENTIRE GLENOID BUILD WAS LOOSE IN THE SHOULDER SPACE. GLENOSPHERE WAS IN PLACE AND ALL POLYAXIAL SCREWS WERE INTACT. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON CONVERTED THE PATIENT TO A HEMI. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAS BAD RHEUMATOID ARTHRITIS - BONE WAS IN BAD CONDITION. BONE GRAFT WAS NOT USED DURING THE PRIMARY SURGERY. NO TRAUMATIC EVENT REPORTED AND ALL GLENOID POLYAXIAL LOCKING SCREWS WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195136 REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25 SHOULDER REVERSE SYSTEM GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 2201532 07630040708098

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention