Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening (MDA/2019/006)

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.

Action by

  • Medical directors
  • Orthopaedic departments
  • Orthopaedic surgeons
  • Staff involved in the management of patients with joint replacement implants

Deadlines for actions

Actions underway: 15 February 2019 Actions complete: 01 March 2019

Medical Device Safety Officers (in England)

Ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.

Remember

If your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from the MHRA.

Device details

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.

Problem / background

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.

Manufacturer contacts

Stryker GmbH
c/o Stryker T&E Post Market Safety
Bohnackerweg 1
CH – 2545 Selzach
Switzerland

Tel: +41 (0)79 904 3871

tnepfa@stryker.com

Distribution

If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.

Trusts (NHS boards in Scotland)

CAS and NICAS liaison officers for onward distribution to all relevant staff including:

  • Fracture clinics
  • Orthopaedic surgeons

Independent distribution

  • Establishments registered with the Care Quality Commission (CQC) (England only)
  • Hospitals in the independent sector *Independent treatment centres

Please note

CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: safetyalerts@dmhra.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to the MHRA, quoting reference number MDA/2019/006 or 2017/010/016/701/063.

Technical aspects

Hasan Samee-Ahmed, MHRA

Tel: 020 3080 6807

Email: hasan.samee-ahmed@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA

Tel: 020 3080 7274

Email: dct@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety

Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

https://www.health-ni.gov.uk/niaic

To report an adverse incident involving a medical device in Northern Ireland use the forms on our website.

Alerts in Northern Ireland are distributed via the NICAS system.

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland

Tel: 0131 275 7575

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account. For more information, or if you can’t access the webform, visit the website: how to report an adverse incident

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government

Tel: 02920 823 624 / 02920 825 510

Email: Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download documents

Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening (MDA/2019/006)

Published 8 February 2019
Last updated 8 February 2019 + show all updates
  1. Updated MDA attachment
  2. First published.