BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUEPRINT SOFTWARE

    MDR report key: 21162095 · Received January 15, 2025

    Report

    Report Number
    3000931034-2025-00037
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 16, 2024
    Report Date
    March 6, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    QHE
    PMA / PMN Number
    K232265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE CORRECTION TO D3 (MANUFACTURER ENTITY) AND G1 (MANUFACTURING SITE). ADDITIONALLY, IT HAS BEEN NOTED THAT THE FDA REGISTRATION NUMBER SHOULD BE 301066773 - TE (ARLINGTON). AFTER REVIEW OF THE RISK DOCUMENTATION AND THE REPORTED INFORMATION REGARDING THE REPORTED EVENT, IT NOTED THAT THIS EVENT DOES NOT SUGGEST THAT A RECURRENCE OF THIS EVENT WOULD RESULT IN A SERIOUS INJURY OR DEATH. LASTLY, UPON A REVIEW OF THE COMPLAINT HISTORY OF THE DEVICE, IT HAS BEEN NOTED THAT THERE IS NO REPORTS OF SERIOUS INJURY OR DEATH AS A RESULT OF SIMILAR EVENTS WITH THIS DEVICE. THEREFORE, MFR REPORT # IS NOW DEEMED NOT REPORTABLE AND SUBSEQUENTLY CANCELLED. IF FURTHER INFORMATION BECOMES AVAILABLE THAT SUGGESTS OTHERWISE, THE REPORTING DECISION WILL BE REEVALUATED.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "DR. (B)(6) IS GETTING AN ERROR WHEN HE TRIES TO LOAD THIS CASE. THE PATIENT WAS SUPPOSED TO HAVE SURGERY TODAY BUT HAS BEEN POSTPONED SINCE THEY CAN'T GET BP TO WORK.".

    Description of Event or Problem · 0

    AS REPORTED: "DR. (B)(6) IS GETTING AN ERROR WHEN HE TRIES TO LOAD THIS CASE. THE PATIENT WAS SUPPOSED TO HAVE SURGERY TODAY BUT HAS BEEN POSTPONED SINCE THEY CAN'T GET BP TO WORK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364397 BLUEPRINT SOFTWARE SHOULDER ARTHROPLASTY IMPLANTATION SYSTEM QHE WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown