Safety Information

Revised: 2 November 2012

DePuy ASR and ASR-XL Metal-on-Metal Hip Implants

Quetions and Answers

In 2010 DePuy International Ltd, a subsidiary of Johnson & Johnson, recalled the ASR range of metal-on-metal hip implants due to higher than anticipated rates of replacement surgeries.

Below are some questions and answers to assist with understanding the issue affecting DePuy ASR Metal-on-Metal hip implants.

General Information about Metal-on-Metal hip implants

What is the problem with the ASR hip?

A definitive cause for the early revision of ASR hip implants has not yet been determined.

All implantable devices wear out in time and may need replacement (revision) surgery. The DePuy ASR hip was found to be requiring revision earlier than other similar devices.

Implantation of artificial joints is a complicated procedure that has many variables which affect the outcome of the surgery. Over time orthopaedic implants may require full or partial replacement, a process known as revision. Reasons for revision include: loosening, positioning problems, wear, or falls/accidents. Joint registries and the implant manufacturers monitor trends in revisions and their causes.

The data collected by joint registries in Australia and the UK indicated that a higher proportion of the ASR hip joints required revision compared to other hip replacements. This was unexpected and led to DePuy taking the current action.

What did DePuy do in response to this matter?

DePuy contacted Medsafe and other regulators in August 2010 and advised of their intention to issue a type of recall notice called a Hazard Alert to advise all orthopaedic surgeons in New Zealand about the potential for patients to require early revision of their implant and to offer assistance with management of those patients. Medsafe agreed that the action was appropriate and the Hazard Alert was distributed to 31 surgeons trained in the implantation of ASR devices, and to 218 general orthopaedic surgeons.

The Hazard Alert recommended that surgeons contact their patients and advise them of this issue. All of the surgeons trained in the implantation of ASR devices acknowledged receipt of the Hazard Alert.

Surgeons were also supplied with a patient letter, to assist in explaining the issues to their patients.

The patient letter included the following statement.

DePuy plans to cover reasonable and customary costs of care if you need them, including revision surgery if it is necessary, associated with the ASR recall. DePuy is finalising the process of how your costs will be reimbursed and how the claims centre will work in New Zealand. Where possible DePuy plans to pay your surgeon or hospital directly for costs of your care, including if you have to have revision surgery.

Link to DePuy ASR Patient Information Sheet (Microsoft Word document 46KB)

DePuy recommended that only patients experiencing problems such as pain or stiffness should have their implants revised. The majority of patients have not experienced problems with their implants. Revision of a hip implant is major surgery and should only be performed following consultation and agreement with the surgeon.

DePuy established an 0800 freephone number for patients to call should they wish to discuss their implants. The number is 0800-660-026.

How many people in New Zealand have the ASR hip implanted?

A total of 525 ASR hip systems were implanted into approximately 400 people in New Zealand between 2004 and 2010.

Medsafe understands that the total number of metal-on-metal hip replacements performed between 2000 and 2011 was 6,225 of which 525 (8.4%) were DePuy ASR devices.

Why weren't patients contacted directly by DePuy or Medsafe?

The right of patients to confidentiality prevents the release of patient information to third parties, such as DePuy or Medsafe, in order to protect their privacy. It is the professional responsibility of the healthcare professional to contact their patient when advised of safety issues. This is part of their duty of care and is not transferable to third parties who are not health and disability service providers. Patients with ASR devices need to discuss the issue with their surgeons who are familiar with their history so that they can make a clinical plan best suited to the patient's circumstance.

What should I do if I think I have a DePuy ASR hip implant?

Firstly discuss your situation with your surgeon or GP. They will be able to confirm what type of implant you have received.

If you experience any symptoms including; hip/groin pain, local swelling, numbness, or changes in your ability to walk, contact your doctor or surgeon to let them know so that they can advise you on further follow-up or treatment.

If you have a metal-on-metal implant and you are not experiencing any symptoms it is important for you to continue to see your doctor or surgeon for regular follow-up. This monitoring may involve routine X-rays to check the positioning of the implant, and other tests.

Link to information from the US Food and Drug Administration (FDA) for patients with Metal-on-Metal hip joints

Link to information from the Australian Therapeutic Goods Administration (TGA) for patients with DePuy ASR hip joints