Medical Device & Consumer Products Recalls
DePuy (MoM) hip replacements Recalls. In August 2010, DePuy Orthopaedics, a division of Johnson & Johnson, issued a voluntary recall of the ASR™ Resurfacing System. This was as a consequence of new information from the UK National Joint Registry which indicated that the number of patients who required a second hip replacement procedure, called a revision surgery, was not in line with data previously reported by DePuy.
What are the Orthopaedic Surgeons saying?
Approximately 3,500 Irish people have been affected by the recall of DePuy’s ASR Hip Resurfacing System and the ASR Total Hip Replacement. Research by the British Orthopaedic Association has found that the rate of necessary revision surgeries for patients who received a DePuy ASR Hip Implant may be much higher than previously thought. The research indicates a revision rate ranging from 21% after four years to 49% after six years, nearly four times as high as the figures cited by DePuy in August 2010. Read More
On Tuesday 28th February, 2012 the Medicines and Healthcare products Regulatory Agency (MHRA) issued an Updated Device Alert relating to all MoM hip replacements. The MHRA advised surgeons that patients who had this type of hip medical device should be monitored annually for the life time of the patient. This advice is based on recently updated evidence that patients with MoM hip replacements with head diameter of 36 millimetres or more need to be monitored every year. The Irish Medicines Board (IMB) has written to all Orthopaedic Surgeons and those involved in the management of patients, of joint hip replacements advising of the MHRA Medical Device Alert.
Conclusions from the most recently published research are that the DePuy MoM hip device problems may extend to other MoM hip implant manufactures. It appears that these problems are taking longer to manifest themselves. The Lancet is one of the world’s leading medical journals and in a recent article “Failure rates of stemmed MoM hip replacements”, the authors, renowned experts in their field; recommended that MoM bearing surfaces are not used in stemmed hip replacements. Read More
Safety always comes first when you are thinking about buying a product for you or your child. A consumer product that is commercially produced and distributed will be considered to be defective if it does not meet the legitimate expectations of the person buying it. There are many types of defective consumer products.
- Household appliances and electrical goods.
- Children’s clothing and dangerous toys.
- Sports and recreational equipment.
- Outdoor furniture and gardening equipment.
The National Consumer Agency is responsible for market surveillance in respect of the safety of a wide range of non-food consumer products. They enforce product safety legislation, investigate complaints, alert consumers about unsafe products and give advice to manufacturers, distributors, retailers and their representative organisations. Read More