BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AGC

    MDR report key: 6509983 · Received April 20, 2017

    Report

    Report Number
    0001825034-2017-02690
    Event Type
    Injury
    Date Received
    April 20, 2017
    Report Date
    June 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPLAINT WAS FOR A REQUEST FOR PRODUCT IDENTIFICATION ONLY. THERE WAS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR PERFORMANCE OF THE PRODUCT. AS SUCH, THIS INFORMATION IS CONSIDERED AN INQUIRY AND THE COMPLAINT FILE IS BEING CLOSED AS NOT A COMPLAINT. IF ADDITIONAL INFORMATION IS RECEIVED THAT ALLEGES A PRODUCT DEFICIENCY, THE COMPLAINT WILL BE RE-OPENED AND EVALUATED AT THAT TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT MAY REQUIRE A REVISION PROCEDURE DUE TO UNKNOWN REASONS. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288330 UNKNOWN AGC PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention