Events

Safety Alert Or Field Safety Notices for Shoulder system

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 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
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2017/023
  • Date
    2017-08-18
  • Event Date Posted
    2017-08-18
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/shoulder-system-comprehensive-nano-humeral-components-increased-risk-of-revision-when-used-in-reverse-configuration
  • 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
    Data collected by the manufacturer indicates that the Comprehensive Nano Humeral Component did not meet the expected performance rate (EPR) when used in the reverse configuration.
    Therefore, the manufacturer has changed the indication for use and it must no longer be used in the reverse configuration. The component may still be used in the anatomic configuration.MHRA is issuing this advice to ensure that you are aware of the change in indication for use and take appropriate action.
  • Reason
    Manufactured by zimmer biomet – do not use this device in the reverse configuration. (mda/2017/023).
  • Action
    Immediately stop using the affected items in the reverse configuration. Read the manufacturer’s Field Safety Notice for further information. Complete the certificate of acknowledgment attached to the Field Safety Notice and return it to the manufacturer. Monitor patients who have already been implanted with this device in the reverse configuration for signs of loosening on X-ray1 for 2 years post-implantation. Advise patients to contact their implanting centre if they experience any increased pain or loss of shoulder movement or if their shoulder suddenly changes shape. Report all adverse events involving this device to Zimmer Biomet and to MHRA or the appropriate Devolved Administration.

Device

Shoulder system
  • Model / Serial
  • Product Description
    The following components are affected:Device Identifier Item Number Product Description Size NHS Supply Codes (01)00880304530898 115730 Comprehensive Nano Humeral Component PPS 30mm FQS196 (01)00880304530904 115732 Comprehensive Nano Humeral Component PPS 32mm FQS197 (01)00880304530881 115734 Comprehensive Nano Humeral Component PPS 34mm FQS198 (01)00880304530935 115736 Comprehensive Nano Humeral Component PPS 36mm FQS199 (01)00880304530911 115738 Comprehensive Nano Humeral Component PPS 38mm FQS200 (01)00880304530928 115740 Comprehensive Nano Humeral Component PPS 40mm FQS201
  • Manufacturer
    Zimmer Biomet

Manufacturer

Zimmer Biomet
  • Manufacturer Address
    Zimmer Biomet Mr Grayham Burnell, Corrective Action Co-ordinator, Complaints Department, UKTel: 01656 678 308 grayham.burnell@zimmerbiomet.comIf you haven’t yet returned the certificate of acknowledgement form attached to the Field Safety Notice, please contact Mr Grayham Burnell.
  • 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