Events

Safety Alert Or Field Safety Notices for Comprehensive Reverse Titanium Shoulder Tray (specific lots)

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.

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
  • Date
    2017-04-04
  • Event Date Posted
    2017-04-04
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/comprehensive-reverse-titanium-shoulder-tray-specific-lots-risk-of-device-fracture
  • 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
    In December 2016, Zimmer Biomet issued an FSN informing clinicians of the higher than anticipated rate of fracture of titanium Comprehensive Reverse Shoulder Humeral Trays manufactured prior to September 2011. The affected products were distributed between September 2010 and January 2017.The mean time to fracture is approximately 3 years. The clinical symptoms of device failure include pain, swelling, loss of function and dislocation of the shoulder prosthesis.MHRA is issuing this alert to ensure that clinicians are aware of this issue and consider appropriate follow-up of patients implanted with affected devices.
  • Reason
    Manufactured by zimmer biomet - recall due to increased risk of fracture for all titanium trays manufactured before september 2011 and distributed in the uk between september 2010 and january 2017.
  • Action
    Do not implant Comprehensive Reverse Shoulder Humeral trays from the lots listed in the manufacturer’s field safety notice (FSN) Locate and return all affected products to Zimmer Biomet Identify all patients implanted with the affected device and inform them of this issue Advise patients to contact their orthopaedic surgeon if they develop symptoms such as pain, swelling, dislocation or a change in shoulder shape or function Symptomatic patients should be investigated, which may include imaging such as x-ray to identify a possible fracture of the device Report all adverse events involving the Comprehensive Reverse Shoulder humeral tray to Zimmer Biomet and to MHRA or the appropriate Devolved AdministrationsIn all cases, the benefit of ionising radiation screening should be weighed against the risks from radiation exposure on an individual patient basis, in line with the requirements of the Ionising Radiation (Medical Exposure) Regulations 2000.

Device

Comprehensive Reverse Titanium Shoulder Tray (specific lots)
  • Model / Serial
  • Manufacturer
    Biomet

Manufacturer

Biomet
  • Manufacturer Address
    Alison Hope Zimmer Biomet Waterton Point Waterton Industrial Estate Bridgend South Wales Tel: 01656 761 658Email: fieldaction.uk@zimmerbiomet.com
  • 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