Events

Field Safety Notices about Oxford cementless prosthetic knee prosthesis system

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
    2017-03-28
  • 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
    An analysis showed 0.12% of cases in patients worldwide who had fractures of the tibial plateau. an analysis of reported complaints has yielded results showing that, in the event of a fracture, tibia was identified by the orthopedic surgeon on average 25 days after the primary surgery, and available data indicates that 17% of these fractures were treated conservatively. the cementless oxford tibial trays were manufactured according to predefined specifications. an investigation into the cause of reported tibial plateau fractures has shown that it is important to follow certain steps outlined in current surgical techniques to reduce the risk of tibial plateau fractures. this notice seeks to emphasize the importance of adhering to the applicable surgical technique and the relevant sections in the package leaflet.

Device

Oxford cementless prosthetic knee prosthesis system
  • Model / Serial
    Article Number Batch numbers 166570, 166571, 166845, 166846, 166572, 166573, 166574, 166575, 166576, 166577, 166578, 166579, __ 166580, 166581 V39 serue 154913,154914,154915,154916,154917,154918, 154919,154920,154921,154922,154923,154924 \ lse serue USl66570, U5166571, U3166845, U5166846, U5166572, USl66573, USl66574, U5166575, U5166576, USl66577, U5166578, U5166579, \ lse serue U5166580, U5166581
  • Manufacturer
    Zimmer Biomet

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