Events

Safety Alert Or Field Safety Notices for Orthopaedic implant rHead Radial Head and Uni-Elbow

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 Stryker.

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
    2019-02-08
  • Event Date Posted
    2019-02-08
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/orthopaedic-implant-rhead-radial-head-and-uni-elbow-risk-of-early-loosening-mda-2019-006
  • 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
    Stryker issued a Field Safety Notice dated November 2017 informing clinicians of the recall of the rHead Radial Head and Uni-Elbow prosthesis. The manufacturer identifies the possibility of post-operative implant loosening (septic and aseptic), instability (moderate/severe), stress fracture (bone), cyst formation (bone resorption), stiffness, pain, impingement, heterotopic ossification with these devices.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 stryker – post-operative loosening of the implant which may require revision surgery.
  • Action
    Do not implant these devices (see details below) Identify and quarantine all affected devices 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. Follow actions recommended in the manufacturer’s Field Safety Notice Report all adverse events involving this device to Stryker and through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

Device

Orthopaedic implant rHead Radial Head and Uni-Elbow
  • Model / Serial
  • Product Description
    All lots of the Stryker rHead Radial Head and Uni-Elbow are affected.The manufacturer’s Field Safety Notice has details of the affected part numbers.
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Manufacturer Address
    Stryker GmbH c/o Stryker T&E Post Market Safety Bohnackerweg 1 CH – 2545 Selzach SwitzerlandTel: +41 (0)79 904 3871tnepfa@stryker.com
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    MHRA