Medical Device Alert: Modular knee/hip replacement systems - MRS Cemented Stems manufactured by Stryker Orthopaedics (MDA/2009/046)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/046 or 2009/003/009/291/011

Technical aspects
Ms Elen Shute or Mr Allan Hidderley
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3281 / 3172
Fax: 020 7084 3106
E-mail: elen.shute@mhra.gsi.gov.uk or allan.hidderley@mhra.gsi.gov.uk

Clinical aspects
Dr Christopher Brittain
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3126
Fax: 020 7084 3111
E-mail: christopher.brittain@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website http://www.mhra.gov.uk
Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx (external link)

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

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

Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900
E-mail: NIAIC@dhsspsni.gov.uk
http://www.dhsspsni.gov.uk/index/hea/niaic.htm

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on our website http://www.dhsspsni.gov.uk/niaic

Further information about SABS can be found at https://sabs.dhsspsni.gov.uk

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

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722
E-mail: iric.nss@nhs.net
http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Enquiries in Wales should be addressed to:

Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922
E-mail: Haz-Aic@wales.gsi.gov.uk 

Small diameter stems (8, 9 or 10 mm) may have been incorrectly implanted in the proximal femur and be at risk of fracture.

The manufacturer recalled various lots of MRS Cemented Stems in its FSN of March 2009. This was because neither the instructions for use nor the product label explained the intended use of different diameters of stem. This Medical Device Alert has been issued to clarify the intended uses of the different stem diameters, and to ensure that patients who have had 8, 9 or 10 mm MRS Cemented Stems implanted in the proximal femur are identified, and receive appropriate advice and follow-up.

All MRS Cemented Stems have the same locking/mating system so the smaller diameter stems would fit with proximal femoral components without the error being detected during surgery. Patients who receive these devices already have significant bone loss so if the stem were to fracture further revision would be difficult. To date the manufacturer is not aware of any cases where such a fracture has occurred.

Of the 84 devices recalled in the UK, two have been confirmed as implanted and 12 were returned to the manufacturer unused. The remaining 70 devices are presumed to have been implanted. The manufacturer cannot exclude the possibility that some of these could have been implanted in the proximal femur.

Review hospital records to identify patients who have had 8, 9 or 10 mm MRS Cemented Stems implanted in the proximal femur.

Consider the need to:

• advise the patient of the additional risk of stem fracture
• advise the patient, particularly if heavier or more active, to avoid excessive impact loading of the affected limb if possible
• offer the patient annual clinical and radiological follow-up where appropriate. For additional radiological examination the benefit should be weighed against the risks from radiation exposure on an individual basis, in line with the requirements of IR(ME)R 2000*
• advise the patient to report any pain or other symptoms as soon as possible.

* SI 2000 No 1769. The Ionising Radiation (Medical Exposure) Regulations 2000.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• HSC Trusts in Northern Ireland (Chief Executives)
• NHS Boards in Scotland (Chief Executives)
• Primary care trusts in England (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• Fracture clinics
• Medical directors
• Orthopaedic surgeons
• Outpatient clinics
• Risk managers 
• Theatre managers
• Theatre nurses

Care Quality Commission (CQC) (England only) to:
Headquarters for onward distribution as appropriate to:

• Hospitals in the independent sector

Change of address or removal from address list for Care Quality Commission:

National Contact Centre
Care Quality Commission
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB

Tel: 03000 61 61 61
E-mail: enquiries@cqc.org.uk

Enquiries to the manufacturer should be sent to:

Jacqueline Fripp
Quality Assurance & Regulatory Affairs
Stryker UK Ltd
Stryker House
Hambridge Rd
Newbury
Berkshire
RG14 5EG

Tel: 01635 262 465
Fax: 01635 262 464
E-mail: jacqueline.fripp@stryker.com