SerenoCem Granules - risk of bone reabsorbtion around granules

Manufactured by Corinthian Surgical Ltd - risk of bone reabsorbtion around granules implanted in the middle ear (MDA/2016/013)

Action

  • Do not implant SerenoCem Granules

  • Return all unused packets of SerenoCem Granules to Corinthian Surgical Ltd

  • Identify all patients implanted with SerenoCem Granules

Clinical advice for the management of implanted patients

Symptomatic Patients:

  • undertake a clinical review and CT scan1
  • consider need for revision surgery with the removal of the granules and obliteration with bone pâté
  • repeat CT scan in 2 years if granules remain implanted

Asymptomatic patients:

  • undertake clinical review and offer a CT scan1
  • repeat CT scan in 2 years to assess the rate of reabsorbtion, for all patients with granules implanted for two years of less, if the initial CT scan shows no or limited reabsorbtion
  • undertake a risk versus benefit assessment if patients request removal of the granules

Report all adverse events involving SerenoCem Granules to Corinthian Surgical Ltd and to the MHRA or the appropriate Devolved Administrations

Action by

  • Medical directors
  • Ear Nose and Throat (ENT) departments
  • Staff involved in the management of patients with SerenoCem Granules

Deadlines for action

Actions underway: 11 August 2016

Actions complete: 24 August 2016

NOTE: These deadlines are for systems to be in place to take actions and not for the completion of patient follow-up and imaging.

Device details

SerenoCem Granules (BCG050) - All Lots

SerenoCem Granules are designed for non-weight bearing applications specifically for use in otologic/maxillofacial surgery as a hard tissue replacement material for obliteration of the mastoid cavity and bone filler.

Corinthian Medical manufactured SerenoCem Granules between 1999 - 2005; Corinthian Surgical Ltd have manufactured SerenoCem Granules since 2006.

Background

Corinthian Surgical Ltd issued a Field Safety Notice dated 18th March 2016 alerting clinicians to this bone reabsorption issue. The definitive root cause of the bone reabsorption has not been established.

MHRA has received reports of bone reabsorption in patients implanted with SerenoCem Granules for obliteration of the mastoid cavity. All patients were reported to be asymptomatic and the bone reabsorption was detected through CT scanning.

The reabsorption has varied from being focal and limited, through to extensive involving the floor of the middle cranial fossa (the tegmen, roof of the mastoid), as well as the posterior fossa dura and the facial canal.

Clinical risks associated with bone reabsorption in the middle ear include, middle ear inflammation (infective or non-infective), progressing to inflammation or infection of the middle and posterior fossa dura, facial nerve and the inner ear. There is therefore a theoretical risk of facial palsy, sensorineural hearing loss and meningitis, although to date there have been no reports of these complications.

Following consultation with clinical experts in Ear Nose and Throat (ENT) departments, MHRA is issuing this medical device alert to ensure that patients receive appropriate follow up.

Manufacturer contacts

Hannah Flemming-Hill
Corinthian Surgical Ltd
2 Church Lane
Brinsley
Nottinghamshire
NG16 5AB

Tel: 01773 778 303

Email: Hannah@corinthiansurgical.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 SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • Audiology departments
  • Clinical governance leads
  • Cochlear implant units directors
  • ENT departments
  • ENT medical staff
  • ENT services, directors of
  • Medical directors
  • Purchasing managers
  • Radiology directors
  • Risk Managers
  • Theatre managers
  • Theatre nurses
  • Theatres

NHS England area teams

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

  • General practitioners
  • General practice managers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Hospitals in the independent sector
  • Private medical practitioners

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 Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2016/013 or 2016/004/007/291/013.

Technical aspects

Bayode Adisa, MHRA

Tel: 020 3080 7223

Email: bayode.adisa@mhra.gsi.gov.uk

Clinical aspects

Mark Grumbridge, MHRA

Tel: 020 3080 7128

Email: mark.grumbridge@mhra.gsi.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NI SABS system

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

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

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

Reporting adverse incidents in Northern Ireland

Please report directly to NIAIC using the forms on our website.

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
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.

Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.

Private facilities providing care to private clients report to the Care Inspectorate and MHRA.

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 document

SerenoCem Granules - risk of bone reabsorption around granules (MDA/2016/013)

  1. In all cases, the benefit of ionising radiation screening should be weighed against the risks from radiation exposure on an individual patient basis, in line with the requirements of The Ionising Radiation (Medical Exposure) Regulations 2000. 2

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