SerenoCem Granules - risk of bone reabsorbtion around granules
- Medicines and Healthcare products Regulatory Agency
- 4 August 2016
- 4 August 2016
- Alert type:
- Medical device alert
Manufactured by Corinthian Surgical Ltd - risk of bone reabsorbtion around granules implanted in the middle ear (MDA/2016/013)
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
- 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
- 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
- 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.
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.
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.
Corinthian Surgical Ltd
2 Church Lane
Tel: 01773 778 303
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
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practitioners
- General practice managers
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: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/013 or 2016/004/007/291/013.
Bayode Adisa, MHRA
Tel: 020 3080 7223
Mark Grumbridge, MHRA
Tel: 020 3080 7128
Reporting adverse incidents in England
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,
Department of Health,
Social Services and Public Safety
Tel: 028 9052 3868
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
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
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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 4 August 2016
Issued: 4 August 2016
Alert type: Medical device alert