Events

Field Safety Notices about Various polyethylene implants

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
    2017-02-17
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • 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
    Zimmer biomet is implementing a field-based action on medical devices for various polyethylene implants, depending on the lot. the products concerned are being withdrawn due to the possible presence of increased endotoxin levels beyond the specification limit. the problem was identified during routine testing for the presence of bacterial endotoxin (bet). no complaints were received regarding this issue.   endotoxins (pyrogens) are substances found in certain bacteria. the standard for endotoxin levels, as adopted by the us food and drug administration (fda), is 20 eu / gadget. three polyethylene sample implants were found to be in excess of this level over a period of about 6 weeks. as a result, polyethylene implants manufactured during this period are withdrawn from the market. the products concerned, which have the potential to exceed the limits for endotoxins, could pose the potential risks described below:.

Device

Various polyethylene implants

Manufacturer

Zimmer Biomet
  • 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
    AMPMDRS