BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC COMPLETE PRIMARY FEMORAL

    MDR report key: 12300498 · Received August 10, 2021

    Report

    Report Number
    12300498
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 17, 2021
    Report Date
    July 26, 2021
    Manufacturer
    BIOMET ORTHOPEDICS, LLC
    Product Code
    KWL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE (HIP REVISION) THE SURGEON EXPLANTED THE FEMORAL STEM FROM THE PATIENT. AFTER THE STEM WAS EXPLANTED, THE SURGEON NOTICED AN AREA OF THE POROUS COATING WAS CHIPPED FROM THE STEM. THE STEM REFERENCE #51-103140, LOT 6743500. THE SURGEON REQUESTED THE ZIMMER SALES REPRESENTATIVE TAKE THE EXPLANT BACK TO THE MANUFACTURER. THE EXPLANT WAS REMOVED FROM THE STERILE FIELD AS IS AND DOUBLE BAGGED AND GIVEN TO THE SALES REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198337 TAPERLOC COMPLETE PRIMARY FEMORAL PROSTHESIS, HIP, HEMI-, FEMORAL, METAL KWL BIOMET ORTHOPEDICS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA