How to report adverse incidents
Please use our online reporting systems - there is a specific option 'Hip or knee implants'.
To report on other trauma and orthopaedic implants, use the 'General report form/all other devices' section.
We have specialists who investigate adverse incidents for:
- joint replacements (hip/knee/shoulder/elbow replacements etc, ligaments, bone cement, synovial fluid replacements)
- trauma/osteosynthesis (internal/external fixation including bone screws, plates, nails etc, bone substitutes)
- spinal implants (total disc replacements, spinal fusion and stabilisation devices.
We have produced a poster for orthopaedic theatres, to promote reporting adverse incidents and to help us identify poorly performing implants.
Information for manufacturers
Which orthopaedic and trauma adverse incidents to report
Guidance on the type of joint replacement incident which should be reported is available in 'Joint replacement implants - guidance on the vigilance system'. Guidance on other medical device reports is given in the first Device Bulletin of the year.
How to monitor implant performance
In 1998 the Medical Devices Agency 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 the document 'Post-market surveillance of CE marked joint replacement implants including guidance to manufacturers on post-market clinical studies' in our regulatory publications section.
NICE guidance on primary total hip replacements and metal-on-metal hip resurfacing arthroplasty
In April 2000 the National Institute for Health and 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 England and Wales for hip, knee and shoulder 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.
Reports of Expert Advisory Groups
Soft tissue reactions associated with metal-on-metal hip replacements. October 2010
The MHRA has received reports of revisions of metal-on-metal hip replacements due to soft tissue reactions which are in some instances associated with unexplained pain.
An Expert Advisory Group (EAG) involving members of the British Hip Society (BHS), the British Orthopaedic Association (BOA), the Medicines and Healthcare products Regulatory Agency (MHRA), and the National Joint Registry of England and Wales (NJR) was set up to look at the incidence of this problem and to make recommendations about the management of patients implanted with metal-on-metal hip replacements.
The report of the EAG
(224Kb), including recommendations for patient management, is also available on the BOA website (www.boa.ac.uk). A programme of identification and review of patients has already been initiated to follow up the recommendations given in the report.
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 the MHRA regarding this issue.
Medical Device Alerts on orthopaedic implants
- MDA/2010/069 September 2010. ASR™ hip replacement implants manufactured by DePuy International Ltd.
- MDA/2010/033 Apr 2010. All metal-on-metal (MoM) hip replacements.
- MDA/2009/062 Oct 2009.Knee replacement implant manufactured by DePuy International Limited.
- MDA/2009/046 Jul 2009 Modular knee/hip replacement systems - MRS Cemented Stems manufactured by Stryker Orthopaedics.
- MDA/2009/037 Jun 2009. Knee replacement implant manufactured by DePuy International Limited.
- MDA/2009/016 Feb 2009 - Total knee replacement implant femoral components – PFC SIGMA. Manufactured by DePuy International Limited
- MDA/2008/067 Sep 2008 - Instrumentation for total knee replacement surgery: NexGen Articular Surface Insertion Instrument manufactured by Zimmer Inc
- MDA/2008/066 Sep 2008 - Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts
- MDA/2008/003 Jan 2008 - Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers)
- MDA/2007/092 Dec 2007 - Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers)
- MDA/2007/088 Nov 2007 - Injectable polymeric cements used in percutaneous vertebroplasty, balloon kyphoplasty and pedicle screw augmentation
- MDA/2007/084 Nov 2007 - Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system
- MDA/2007/081 Oct 2007 - Orthopaedic bone cement restrictor instrumentation. DePuy SmartSeal™ pressurisers - femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW
- MDA/2007/076 Oct 2007 - Bioresorbable screw: CALAXO interference screw implants manufactured by Smith & Nephew Inc
- MDA/2007/068 Sep 2007 - Hip implants for hemiarthroplasty - Austin-Moore, F.R. Thompson and Thompson Modular endoprostheses manufactured by Biomet
- MDA/2007/067 Aug 2007 - Hip resurfacing implants. Adept acetabular cups manufactured by Finsbury Orthopaedics
- MDA/2007/063 Aug 2007 - Hip resurfacing implants. Birmingham Hip Resurfacing (BHR) acetabular cups manufactured by Smith & Nephew Orthopaedics Ltd
- MDA/2007/054 Jun 2007 - Total hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation
- MDA/2006/046 August 2006. 'Orthopaedic implants manufactured by Proconcept SA France: CIFEC cervical cages; LIFEC lumbar cages; ALIFEC lumbar cages; SRE/SEO spinal screw systems; CANALETTO carpal tunnel protection implants'.
- MDA/2004/011 March 2004. 'ABG1 uncemented acetabular cups for total hip replacement'. Stryker UK / Hownedica International Ltd.
- MDA/2004/009 February 2004. 'Moje press-fit ceramic toe joint prosthesis'. Moje Ceramic Implants / Orthosonics Ltd.
- SN 2002(05) February 2002. 'Ceramic femoral head'. Various manufacturers.
- DA 2001(06) September 2001. 'Hylamer components sterilised by gamma irradiation in air'. DePuy International Ltd.
