BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET AGC V2 INTERLOK TIBIAL 22X 67MM

    MDR report key: 6649011 · Received June 16, 2017

    Report

    Report Number
    0001825034-2017-04098
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    May 16, 2017
    Report Date
    June 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRY
    PMA / PMN Number
    PSEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K921182. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. DURING THE SURGERY, IT WAS DISCOVERED THAT THE STERILE PACKAGING HAD SOME KIND OF SUBSTANCE ON IT. THE SURGERY WAS DELAYED FOR ONE HOUR DUE TO THE CONCERN OF STERILITY OF THE DEVICE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429737 BIOMET AGC V2 INTERLOK TIBIAL 22X 67MM PROSTHESIS, KNEE HRY BIOMET ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization