Events

Safety Alert Or Field Safety Notices for Austin-Moore, F.R. Thompson and Thompson Modular endoprostheses

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Biomet UK Ltd.

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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2007/068
  • Event Number
    CON2032272
  • Date
    2007-09-05
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032272
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Recall due to potential failure of sterile barrier packaging which could compromise product sterility. biomet uk is recalling certain lots of austin-moore, f.R. thompson and thompson modular endoprostheses because the sterile barrier packaging has become brittle with age. failure of the sterile barrier packaging could compromise product sterility. the manufacturer has stated that packaging embrittlement is obvious to users and it should be immediately apparent that the product should not be used. neither the manufacturer nor the mhra is aware of any reports of adverse patient effects arising from this problem. only devices with the lot numbers and expiry dates listed above are affected by this recall.
  • Action
    Identify and quarantine any unimplanted affected devices. Do not implant affected devices. Return affected devices to the manufacturer.

Device

Austin-Moore, F.R. Thompson and Thompson Modular endoprostheses
  • Model / Serial
  • Product Description
    Hip implants for hemiarthroplasty – Austin-Moore, F.R. Thompson and Thompson Modular endoprostheses manufactured by Biomet UK Ltd. Austin-Moore Endoprostheses (catalogue numbers ST609-38 to ST609-55, ST610-38 to ST610-55, ST612-38 to ST612-55, ST613-5 to ST613-95). F.R. Thompson Endoprostheses (catalogue numbers ST611-38 to ST611-55). Thompson Modular Endoprostheses modular stems (catalogue numbers 164556 to 164558). For all the above, affected lot numbers are within the range 388000 to 443000 and expiry dates are between September 2010 (2010-09) and April 2011 (2011-04).
  • Manufacturer
    Biomet UK Ltd

Manufacturer

Biomet UK Ltd
  • 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
    MHRA