Events

Safety Alert Or Field Safety Notices for DePuy Synthes Radial Head elbow prosthesis 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 Synthes GmbH.

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
    2017-06-12
  • Event Date Posted
    2017-06-12
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/depuy-synthes-radial-head-elbow-prosthesis-system-risk-of-post-operative-loosening-of-the-radial-stem
  • 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, DePuy-Synthes issued a Field Safety Notice informing clinicians of the recall of the Radial Head prosthesis due to the possibility of post-operative loosening of the stem at the stem-bone interface. Implant loosening may lead to osteolysis, poor joint mechanics, bone fracture or soft tissue damage.The radial stem was introduced into the UK market in 2015 and up to the publication date of this medical device alert, MHRA has received no reports of stem loosening.
  • Reason
    Manufactured by synthes gmbh - recall of radial head prosthesis system. associated radial head prosthesis system parts also need to be returned to depuy synthes but will be available for revision surgeries of the radial head component.
  • Action
    Do not implant these devices (see details below). Locate and return all affected products to DePuy Synthes as detailed in their Field Safety Notice. Identify and advise all patients implanted with affected devices to contact their orthopaedic surgeon if they develop symptoms such as pain, loss of function or instability. Consider monitoring patients at 6 monthly intervals for up to 2 years post-implantation, with both clinical and radiographic assessments (i.e. X-rays1) to identify possible loosening of the radial stem. Any asymptomatic patients identified with loosening of their implants should continue to be monitored at 6-monthly intervals for progressive osteolysis (including potential risk of fracture), or the development of symptoms needing revision surgery. Report all adverse events involving this device to DePuy Synthes and to MHRA or the appropriate Devolved Administration.

Device

DePuy Synthes Radial Head elbow prosthesis system
  • Model / Serial
  • Product Description
    All lots of the DePuy-Synthes Radial Head prosthesis system are affected.For part number and description information for the device and associated parts refer to Attachment 1 of the manufacturer’s Field Safety Notice and the spreadsheet attached to this alert, which includes both catalogue numbers and relevant UDI Device Identifier codes (GS1 GTINs).
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH
  • Manufacturer Address
    Martyn Kedie Johnson & Johnson Medical Ltd DePuy Synthes Leeds One St Anthony’s Road Leeds, LS11 8DTTelephone: 0113 387 6261Email: MDFieldActionsUKIrl@its.jnj.com
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    MHRA