BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPREP

    MDR report key: 11982737 · Received June 11, 2021

    Report

    Report Number
    11982737
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    April 30, 2021
    Report Date
    June 1, 2021
    Manufacturer
    STRYKER CORPORATION
    Product Code
    JDK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CEMENT RESTRICTOR FROM THE BIOPREP BONE PREPARATION SYSTEM BROKE DURING PATIENT'S PROCEDURE. ANATOMICALLY, CANAL WAS NOTED AS NARROW WHERE THE CEMENT RESTRICTOR WAS PLACED. THE INSERTER HANDLE BECAME STUCK IN CANAL. THE PLASTIC INSERTER HAD TO BE CUT AND REAM THE CANAL FREE. INCREASED LENGTH OF TIME FOR PROCEDURE. THE PATIENT DEVELOPED POST OPERATIVELY ARTERIAL OCCLUSION REQUIRING VASCULAR CONSULT/INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879900 BIOPREP PROSTHESIS, HIP, CEMENT RESTRICTOR JDK STRYKER CORPORATION 0206710000 21060012

    Patients

    Seq Age Sex Outcome Treatment
    1 28835 DA Other