BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 42MM

    MDR report key: 21208419 · Received January 22, 2025

    Report

    Report Number
    0001649390-2025-00037
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 22, 2025
    Manufacturer
    TORNIER INC
    Product Code
    PXH
    UDI-DI
    00846832090358
    PMA / PMN Number
    K161742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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 ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "EXPLANT RIGHT RSA WITH PLACEMENT OF ANTIBIOTIC CEMENT SPACER FOR INFECTION." THE SHOULDER HAD BEEN DRAINING PUSS FOR A LONG TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650894 TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 42MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PXH TORNIER INC UNKNOWN 00846832090358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention