Orthopaedic surgeons' section

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Hot topics
› Committee on the Safety of Devices: New members required - updated 1 October 2008
› 6 August 2008 - The MHRA is aware that Zimmer Inc. has suspended marketing and distribution of their Durom acetabular component in the United States. The Durom acetabular component is used for both total hip replacement (THR) and hip resurfacing in Europe, but is only licensed for THR in the USA.

The manufacturer has stated that the reason for the suspension is a problem with surgical technique and labelling that is restricted to the US and does not affect devices implanted in the UK. Further information about the background to this issue can be found on the Zimmer Inc. website: http://www.zimmer.com/web/enUS/pdf/Durom_Backgrounder_on_Status_7-22-081.pdf (external link).

A review of the MHRA adverse incident database has not revealed any reports to MHRA of similar problems in this country. However, we are investigating whether there are any implications for surgeons and patients in the UK, and will consider the need to issue advice if necessary. If you do experience problems with this component, or any other orthopaedic implant, please report this to us via our online report forms.


Orthopaedic Medical Device Alerts
Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. Medical Device Alerts (MDAs) are the MHRA's prime means of communicating safety information to medical device users in health and social care. Each MDA is designated either for Immediate action or Action. MDAs may also be used to provide updated information.

2008 to present
› September 2008 - Zimmer is initiating a product recall of the NexGen® Complete Knee Solution Articular Surface Insertion Instrument, involving Catalogue Number 00-5977-020-00, Lot Numbers 60577285, 60582624, 60587308, 60603255, & 60610860.
› September 2008 - Stryker Orthopaedics are recalling some Kinemax Plus Revision TS Tibial Inserts as there may be a risk of loosening, excessive wear and fracture of knee replacement components, due to a manufacturing defect.
› June 2008 - A limited number of electrosurgical single-use, sterile blades and needles. ‘Universal’ and ‘Ultraclean’ electrodes manufactured by ConMed may have an inadequate packagaing seal, potentially compromising the sterility of the device 
› April 2008 - Holes have been discovered in the corners of the blister packagin for these surgical blades manufactured by ConMed Linvatec Hall®
› January 2008 - The manufacturer has extended the recall of VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd which may have incorrect alloy composition

2007
› December 2007 - As a result of a manufacturing error, some products have been made from an alloy of incorrect composition, including VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd
› November 2007 - The MHRA have issued updated advice on bone cements used in vertebroplasty and kyphoplasty procedures
› November 2007 - Medtronic is recalling certain lots of Colorado II locking nuts due to a manufacturing defect
› October 2007 - DePuy CMW is recalling SmartSeal™ pressurisers used during cemented total hip joint replacement surgery because the outer peelable pouch seals may be creased and therefore may not be intact
› October 2007 - Smith & Nephew Inc. is recalling all lot numbers and all item codes of CALAXO screws which were first distributed in the UK in 2006. This screw is used to secure the graft in anterior cruciate ligament (ACL) reconstruction
› September 2007 - The manufacturer is recalling certain lots of Austin-Moore, F.R. Thompson and Thompson Modular endoprostheses because the sterile barrier packaging has become brittle with age, compromising product sterility
› August 2007 - Some acetabular cups manufactured by Finsbury Orthopaedics have been labelled with the wrong cup diameter
› August 2007 - Inappropriate mixing of head and cup sizes of Birmingham Hip Resurfacing (BHR) acetabular cups manufactured by Smith & Nephew Orthopaedics Ltd due to incorrect labelling of the cups, which may require early revision due to loose joint fit
› June 2007 - Early revision due to periprosthetic soft tissue necrosis of DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation

Before 2007
› August 2006 - Invalid CE certification of 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
› March 2004 - Cup wear and asymptomatic acetabular osteolysis in uncemented acetabular cups for total hip replacement

Recent Drug Alerts
If a defective medicine is thought to be a risk to public health, the product is withdrawn from the market and information from the MHRA issued:
›June 2008 - An update on the supply situation and clinical advice concerning enoxaparin (Clexane) pre-filled syringes contaminated with over-sulphated-chondroitin sulphate (OSCS)
›April 2008 - Some batches of enoxaparin sodium (Clexane) pre-filled syringes with low levels of over-sulphated-chondroitin-sulphate (OSCS) have been distributed in the UK
›November 2007 - Suspension of UK licences for Lumiracoxib due to severe hepatotoxicity

Recent MHRA orthopaedic guidance and publications
› Report by Expert Advisory Group on 'Biological effects of metal wear debris generated from hip implants: genotoxicity'
› Guidance on the Medical Device manufacturer’s vigilance system for CE marked joint replacement implants (175Kb)
› Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from the Microbiology Advisory Committee to Department of Health
› Electrosurgery Poster giving advice on how to prevent injuries to patients and staff when electrosurgery equipment is used
› Orthopaedic implants poster on reporting adverse incidents involving orthopaedic implants

One Liners
All medical devices can fail, but many incidents that result in significant morbidity or mortality arise out of user/device interface problems or because of poor practices. The aim of One Liners is to outline these problems to make users more aware of what can go wrong - it is all too easy to take equipment for granted.

Keeping up-to-date on everything else that goes wrong in hospital? Then read our One Liners:
› One Liners

Down the Drain?
MHRA has received several reports of a wound drain breaking during removal, leaving part of the drain in situ. In some instances, surgical intervention has been necessary to remove the remainder.

A wound drain will be weakened and liable to break on removal if it is partially cut or nicked during use. Users should be aware of this and take particular care not to damage the drain on insertion, when suturing in position, during dressing changes, or on removal of the suture.
› One Liners issue 44 - September 2006

Drug Safety Update - the monthly newsletter from the MHRA and Commission on Human Medicines
Our monthly electronic newsletter aims to give the latest advice for all medicines users to ensure the safe use of medicines:

› Drug Safety Update      

Highlights:
› September 2008 - Fentanyl patches: serious and fatal overdose from dosing errors, accidental exposure, and inappropriate use 
› December 2007 - Cardiovascular and gastrointestinal risks associated with NSAIDs and coxibs
› November2007 - Reminder about the withdrawal of co-proxamol drug safety advice for fibrates, lumiracoxib, and St John’s wort
› October 2007 - Advice for the non-steroidal anti-inflammatory drugs piroxicam, ketoprofen, and ketorolac
› September 2007 – Corticosteroids and their early psychiatric side-effects.

Interactive education modules
Do you understand how diathermy works and its associated risks?
› An interactive teaching session on diathermy – highly recommended if you forgot to prepare for your lunchtime teaching session!

This anaesthetic educational package looks briefly at the history of the anaesthetic machine and then covers the basic principles involved in the safe use of anaesthetic machines.

Have you thought about...
› Helping your patients stop smoking?

The possible effects a patient’s herbal medicine may have?
› Herbal safety advice

NICE produces guidance in three areas of health:

• Public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector.
• Health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS.
• Clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

› National Institue of Clinical Excellence (external link)

Reporting of adverse incidents or adverse drug reactions
Any actual, suspected, potential or avoided adverse event should be reported. Further examples of cases which should be reported are available in the sections below. If in doubt, please report.

You can help us by reporting adverse incidents. These reports enable us to identify medical devices and medicines that are of concern and allow us to take appropriate action.

What should I report if I suspect a medicine is associated with an adverse reaction?
Please complete a Yellow Card to report suspected adverse reactions to prescription medicines, over-the-counter medicines, or herbal remedies. For further information, please see www.yellowcard.gov.uk.  We are particularly interested in receiving Yellow Cards that report serious adverse reactions to established medicines, or that report any reaction for a medicine that is new to the market and carries a black triangle. So that we can assess the Yellow Card, please ensure that you report the suspect drug(s); suspect reaction(s); and basic patient details if known (age, sex, weight, patient's initials, and local identification number for your reference).

Please clarify what a medical device is and what I should report?
Follow this link to a small Q&A session on what a faulty medical device is, and when it should be reported.