Events

Recall of NexGen Complete Knee Solutions Stemmed Tibial Component Precoat

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66714
  • Event Risk Class
    Class 2
  • Event Number
    Z-0480-2014
  • Event Initiated Date
    2013-10-31
  • Event Date Posted
    2013-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123053
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    Two complaints were received in which it was reported that the stem would not lock into the tibia. evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. the taper diameter was found to be oversized by .010.
  • Action
    All distributors will be notified via electronic mail. Hospital risk managers and distributors with affected inventory will also be notified via courier. Surgeons that have implanted this manufacturing lot will be identified and notified by the distributor. Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory, as well as identifying and notifying surgeons that have implanted this manufacturing lot. Distributors will return on-hand affected products to Zimmer and ensure all of their products are accounted for using Attachment 1 provided in the letter. Distributors are to complete and return Attachment 2 indicating which surgeons have implanted the product and to which they have provided notice to. Hospitals that received direct shipments from Zimmer will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product and returning it to their Zimmer sales representative. Communications outside of the United States will occur approximately two weeks after the United States communications. Zimmer will conduct effectiveness checks in the following way: Distributors/Hospitals o 100% of the FedEx notifications will be accounted for o An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned. o Additional notifications via email and FedEx will be sent to those who have not completed the required certification form o Accounts will be deemed unresponsive after 3 attempts. Further questions please call 800-613-6131.

Device

NexGen Complete Knee Solutions Stemmed Tibial Component Precoat
  • Model / Serial
    00-5980-037-02; lot 6228417
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of CA, IN, OH, GA, WI, IA, NE, NJ, PA, NY, MD, NC, AZ, NM, TX, CO, IL, AL, MI, WA, FL and KS, and the countries of China, Japan and Taiwan.
  • Product Description
    NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat || NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; Collagen disorders, and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, varus, or flexion deformities.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA