Events

Safety Alert Or Field Safety Notices for Bone Cement

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
    2018-04-20
  • Event Date Posted
    2018-04-20
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/bone-cement-optipac-40-refobacin-revision-and-optipac-80-refobacin-revision-risk-of-revision
  • 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 2017 Biomet issued a Field Safety Notice informing healthcare professionals that the mechanical strength of the affected batches of bone cement may be reduced increasing the risk of revision. There is also a risk of prolonged surgery from increased polymerisation time when using affected batches of bone cement. The manufacturer suggests it would be prudent to monitor closely affected patients as part of their standard follow-up.This Medical Device Alert is being issued to ensure that all hospitals are aware of the issue and that adequate action is taken to mitigate potential risk to patients.
  • Reason
    Manufactured by biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength.
  • Action
    Identify and quarantine all affected devices. (See table below for affected batches.) Follow actions recommended in the manufacturer’s Field Safety Notice. If at time of use the setting time was longer than indicated in the manufacturer’s instructions for use these patients may require more frequent follow up. For all affected patients, surgeons will need to formulate a local risk assessment and follow-up plan based upon the length of time the device was in storage and relevant patient variables. The affected batches are known to have their mechanical strength reduced by half after 6 months in storage. Complete the certificate of acknowledgment attached to the Field Safety Notice and return it to the manufacturer.

Device

Bone Cement
  • Model / Serial
  • Product Description
    Catalogue number (Manufacturer product code) Product Description Batch/Lot number Use-by date Date of manufacture OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A648C04670 31/05/2018 19/12/2016 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A648C05100 30/06/2018 09/01/2017 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A705B05130 31/07/2018 09/02/2017 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A705B06130 30/09/2018 04/04/2017 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A722B08920 30/11/2018 20/06/2017 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A620A01788 31/01/2018 16/08/2016 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A620A0178A 31/01/2018 23/08/2016 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A705C05628 31/08/2018 30/03/2017 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 B705B05128 31/07/2018 09/02/2017
  • Manufacturer
    Biomet

Manufacturer

Biomet
  • Manufacturer Address
    Zimmer Biomet UK Ltd Peter Bevan Email: Peter.Bevan@zimmerbiomet.comTel: +441656674270 Mobile: +447920007446Peter.Bevan@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