- Do not implant BHR devices in:
- female patients
- patients requiring femoral heads sized 46mm or smaller
- Only use 48mm BHR heads in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measured 48mm at the time of surgery
- Return all unused BHR femoral heads sized 46mm and smaller and their corresponding acetabular and dysplasia cups to the manufacturer
- Follow up patients implanted with BHR hips that fall within the scope of this medical device alert ie:
- all symptomatic patients
- all female patients
- all patients implanted with head sizes 46mm or smaller
- in line with recommendations in the table below (based on the advice given in MDA/2012/036)
|Management recommendations for patients implanted with BHR hips that fall within the scope of this Medical Device Alert|
|Patient follow-up||Annually for the life of the implant|
|Imaging: MARS MRI or ultrasound||Recommended in all cases|
|1st blood metal ion level test||Yes|
|Results of 1st blood metal ion level test||Blood metal ion level >7ppb indicates potential for soft tissue reaction|
|2nd blood metal ion level test||Yes - 3 months after 1st blood test if result was >7ppb|
|Results of 2nd blood metal ion level test||Blood metal ion level >7ppb indicates potential for soft tissue reaction especially if greater than previously|
|Consider need for revision||If imaging is abnormal and/or blood metal ion levels rising|
- Blood metal ion testing to be in whole blood
- 7 parts per billion (ppb) equals 119 nmol/L cobalt or 134.5 nmol/L chromium
- On the basis of current knowledge, this chart has been produced as a guide to the management of these patients. It will not necessarily cover all clinical situations and each patient must be judged individually.
- MARS MRI scans (or ultrasound scans) should carry more weight in decision making than blood ion levels alone
- Patients with muscle or bone damage on MARS MRI are those of most concern. A fluid collection alone around the joint in an asymptomatic patient, unless it is very large can be safely observed with interval scanning.
- Local symptoms include pain and limping
- medical directors.
- orthopaedic departments.
- orthopaedic surgeons.
- staff involved in the management of patients with joint replacement implants.
Deadlines for action
Actions underway: 10 July 2015, actions complete: 24 July 2015
|Catalogue number||Unique device identifier (GS1)|
|BHR acetabular cup|
|BHR dysplasia cup|
Smith & Nephew has identified that certain groups of patients implanted with the BHR system are at a higher risk of revision compared to other groups. This comes from analysis of recent data from the National Joint Registry (NJR) for England, Wales and Northern Ireland.
Smith & Nephew has advised not to use femoral head components sized 46mm in diameter and smaller, and their corresponding acetabular and dysplasia cups; these will be withdrawn from the market. In addition, Smith & Nephew will update the instructions for use for these devices with the following changes:
- BHR will be contraindicated for all female patients
- a warning will be added regarding the restrictions in place for implanting femoral head components sized 48mm in male patients
Smith & Nephew issued a field safety notice dated 3 June 2015 to communicate these changes to users.
Smith & Nephew Orthopaedics Ltd
Tel: 01926 482 385
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- clinical governance leads
- clinical pathologists
- clinical pathology directors
- NHS walk-in centres
- nursing executive directors
- orthopaedic surgeons
- outpatient clinics
- outpatient theatre managers
- outpatient theatre nurses
- purchasing managers
- radiology departments
- radiology directors
- risk managers
- supplies managers
- theatre managers
- theatre nurses
- walk-in centres
Public Health England
Directors for onward distribution to:
- collaborating centres
- consultants in communicable disease control
- divisional directors
- heads of department
- heads of health, safety and quality
- health protection nurses
- HPA laboratories
- laboratory managers
- regional business managers
- regional directors • regional epidemiologists • regional leads • regional microbiologists • risk manager • safety officers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- general practitioners
- general practice managers
- general practice nurses
Establishments registered with the Care Quality Commission (CQC) (England only)
- care homes providing nursing care (adults)
- care homes providing personal care (adults)
- hospitals in the independent sector
- independent treatment centres
- nursing agencies
- 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/2015/024 or 2015/006/005/291/012.
Sonal Vara and Michelle Kelly, MHRA
Telephone: 020 3080 7710 / 7145
Dr Camilla Fleetcroft, MHRA
Telephone: 020 3080 6097
Reporting adverse incidents in England
Through the Yellow Card website.
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
Telephone: 028 9052 3868
Fax: 028 9052 3900
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
Telephone: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS boards and local authorities in Scotland should report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients should report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Telephone: 1267 225 278 / 02920 825 510