BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER ID PRM REV GLENOID 35MM POST CENTERED 25MM

    MDR report key: 21489146 · Received February 28, 2025

    Report

    Report Number
    0001649390-2025-00117
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    November 19, 2024
    Report Date
    April 23, 2025
    Manufacturer
    TORNIER INC
    Product Code
    PHX
    UDI-DI
    00840338604248
    PMA / PMN Number
    K211359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED, AND THE LOT NUMBER WAS NOT COMMUNICATED. INDICATIONS OF MATERIAL MANUFACTURING OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED THE INVESTIGATION REPORT WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "SUBJECT: (B)(6) SHOULDER ID STUDY. SENSORY AND/OR MOTOR DISTURBANCE - BRANCH NEUROPATHY. PT REPORTED THAT ~2 WEEKS POST-OP, HE BEGAN EXPERIENCING NUMBNESS IN HIS RIGHT RING AND PINKY FINGERS."

    Description of Event or Problem · 0

    AS REPORTED: "SUBJECT: 004-019 SHOULDER ID STUDY SENSORY AND/OR MOTOR DISTURBANCE - BRANCH NEUROPATHY PT REPORTED THAT ~2 WEEKS POST-OP, HE BEGAN EXPERIENCING NUMBNESS IN HIS RIGHT RING AND PINKY FINGERS.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030761 SHOULDER ID PRM REV GLENOID 35MM POST CENTERED 25MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX TORNIER INC UNKNOWN 00840338604248

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other