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DePuy Hip Device Recall

Stephen Moore Reports on Defective Hip Replacement Compensation Claims

Metal-on-metal hip replacement devices manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, were recalled by the Medicines and Healthcare Products Regulatory Agency (MHRA) in August 2010. These devices have been in clinical use in the UK since July 2003. Recalled products include the 'ASR XL Acetabular System', which is a total hip replacement and the 'ASR Hip Resurfacing System', which is used to preserve more of the hip joint. These implants account for around 10,000 of the metal on metal hips fitted in the UK since 2003.

DePuy issued a voluntary recall of the ASR devices after receiving then unpublished data from a Joint Replacement Registry in the UK. Data indicated that a higher number of ASR patients than previously reported needed revision surgery earlier than expected. Reports from various medical bodies and DePuy have shown that risks were known since as early as 2005, but the products remained on the market. The Company has reportedly set aside a fund of $3 billion for compensation payments.

Concerns are focused on all-metal hip replacements containing cobalt and chromium. As components of the joint rub together and wear, metal debris can be produced. Potentially toxic metals within this debris can cause inflammation affecting muscle and bone. The toxins can seep into soft tissue, enter the bloodstream and affect the organs, especially the kidneys.

Defective hip symptoms include inflammation and pain, loose hip cups, grinding when walking and metal poisoning.

All patients with these hip products are advised to see a doctor for a blood test. Levels of cobalt and chromium will be measured and they will test for any muscle damage. The MHRA has urged surgeons to schedule all patients for annual follow-up visits. The British Orthopaedic Association and the British Hip Society suggest that data from the ASR XL system shows a rate of revision surgery rising from 21% after four years to 49% after six years. This is considerably higher than DePuy were suggesting.

DePuy products represent a small fraction of the metal on metal implants on the market. A recent BBC report suggests other leading hip devices could also have higher than average failure rates, but there is presently insufficient evidence to be certain. The MHRA has recently advised that approximately 49,000 UK patients with metal on metal hip implants sized over 36 millimetres out of a total of 65,000 were in the high risk category. The MHRA has recommend lifetime annual blood testing and MRI scans if metal levels are shown to be raised.

A representative of DePuy recently speaking to the Daily Mail said the company was working to support patients and reimburse victims and doctors. The MHRA Medical Device Alert relating to metal on metal hip implants can be viewed here:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON143782

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