Field Safety Notices about NexGen LPS Femoral

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Zimmer Biomet.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
  • Event Country
  • Event Source
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    There is a possibility that the foam used in the packaging of the products in question may be too small, which may pierce the internal cavity during transport. zimmer biomet has not received any complaints about the perforation of the internal cavity in the lots concerned.


  • Model / Serial
    00-5964-017-51 63329529 (01) 00889024001152 (17) 260430 (10) 63329529 00-5964-017-51 63342469 (01) 00889024001152 (17) 260430 (10) 63342469 00-5964-017-51 63342472 (01) 00889024001152 (17) 260430 (10) 63342472 00-5964-017-52 63329533 (01) 00889024001169 (17) 260430 (10) 63329533 00-5964-017-51 63329527 (01) 00889024001152 (17) 260430 (10) 63329527
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • 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