Implants for orthopaedics and trauma

We have specialists who investigate adverse incidents and are involved in standards development for :

  • joint replacements (hip/knee/shoulder/elbow replacements etc., ligaments, bone cement, synovial fluid replacements); and
  • trauma/osteosynthesis (internal/external fixation including bone screws, plates, nails etc., bone substitutes)
  • spinal implants (total disc replacements, spinal fusion and stabilisation devices,

Users

How to report adverse incidents
Reports of adverse incidents relating to hip and knee joint replacements should be made by providing as much information as possible on the 'hip & knee' reporting form. For reports on other trauma and orthopaedic implants, use the 'general medical devices' form.

We have produced a poster for orthopaedic theatres, to promote reporting adverse incidents and to help us identify poorly performing implants.

Manufacturers

Which orthopaedic and trauma adverse incidents to report
Guidance on the type of joint replacement incident which should be reported is available in 'Guidance on the medical devices vigilance system for CE marked joint replacement implants'. Guidance on other medical device reports is given in the first Medical Device Alert of the year.

How to monitor implant performance
In 1998 the MDA produced guidance in conjunction with the Association of British Healthcare Industries and the British Orthopaedic Association on best practice in implant surveillance. This can be found in 'Post-market surveillance of CE marked joint replacement implants including guidance to manufacturers on post-market clinical studies'.

Ultra high molecular weight polyethylene (UHMWPE) as an articulating surface in joint replacements

The following safety warnings were published by the Medical Devices Agency (now MHRA):

  • Ultra high molecular weight polyethylene - long term degradation of UHMWPE joint replacement implant components during storage. (MDA Safety Notice SN 9816, April 1998)
  • Highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) components for joint replacement implants - information on long term clinical performance is not yet available. (MDA Safety Notice SN 1999(23), June 1999)

3M Capital hip system
The MDA was a key participant in the drafting of the Royal College of Surgeons' report into the 3M Capital hip system. The press release by the Department of Health (DH) can be found on the DH website, press release number 2001/0298. Copies of the full report (An Investigation of the Performance of the 3M Capital Hip System) and of the patient information leaflet are available from the Royal College of Surgeons (RCS). The RCS report followed the MDA Hazard Notice HN9801 The 3M Capital Hip Replacement. For copies of HN9801 contact the MHRA on tel: 020 7084 3272 or e-mail: dts@mhra.gsi.gov.uk

NICE guidance on primary total hip replacements and metal-on-metal hip resurfacing arthroplasty
In April 2000 the National Institute for Clinical Excellence (NICE) produced a Technology Appraisal Guidance No 2 - 'Guidance on the selection of prostheses for primary total hip replacement'. This was complemented by further guidance in June 2002, which addresses resurfacing hip technology - Technology Appraisal No. 44 - 'Guidance on the use of metal on metal hip resurfacing arthroplasty'.

In March 2005, the NHS Purchasing and Supply Agency published detailed information on the compliance of the primary total hip replacements used in the UK with NICE guidance.

National joint registry for hip and knee replacements
The National Joint Registry (NJR) for hip and knee joint replacements was established on 1 April 2003. The MHRA is a keen supporter of the registry and contributes to the work of the NJR steering committee.

Biological effects of metal wear debris generated from hip implants: genotoxicity
There is new evidence about the biological effects of metal wear debris from hip replacement implants. See the attached statement (34Kb) from MHRA regarding this issue.

MHRA safety warnings on orthopaedic implants


Page last modified: 03 September 2005