BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECTINJECT ON DEMAND HA CEMENT

    MDR report key: 12867775 · Received November 24, 2021

    Report

    Report Number
    0008010177-2021-00048
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 24, 2021
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    GXP
    UDI-DI
    07613327123272
    PMA / PMN Number
    K143661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. THIS COVERS COMPLAINTS REGARDING LOT# D120125, LOT# 121005, AND LOT# D120PQ2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS CLEAR FLUID ACCUMULATION AFTER USE OF DIRECTINJECT BONE CEMENT. A REVISION SURGERY WAS CONDUCTED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769830 DIRECTINJECT ON DEMAND HA CEMENT IMPLANT GXP STRYKER LEIBINGER FREIBURG 79-45910 DI20125 07613327123272

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention