Patient Information - DePuy Hip Recall

DePuy Orthopaedics, Inc. announced in late August 2010 that it was recalling two specific hip replacement implant products.  While this was a worldwide recall, about 3,300 Irish patients received these implants in Ireland, across 16 public and 14 private hospital sites nationwide since 2003. Most of the patients involved in this recall have had had their initial recall appointment.

Patients with queries about their care should contact their Orthopaedic Surgeon or Hospital Team in the first place, but the following detailed questions and answers have been prepared for patients' information. These are being posted to patients involved in the recall during the week of May 23rd 2011.

Updated Patient Questions & Answers       May 2011

Section 1 - Introduction and Background

Section 2 - Initial Recall Appointments

Section 3 - Blood Tests and Metal Ions

Section 4  - Further Treatment or Revision Surgery

                                                   

 

Section 1 Introduction and Background

What products are involved?

This recall involves the DePuy ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System, used in some hip replacement surgeries.

What prompted the recall?

This recall was carried out because an unusually high proportion of patients with these implants required a revision (a second hip replacement operation) following implant of this product.  Information from the National Joint Registry in England and Wales indicates that rates of revision surgery within 5 years after use of either of these products in hip surgery were higher than acceptable: 12% for ASR Hip Resurfacing System and 13% for ASR XL Acetabular System. These compare to revision rates of between 3 and 6%, which were previously recorded.

Who managed this recall process?

An incident management team was set by the HSE to arrange the recall in both public and private hospital sites. The team also included the Irish Institute of Trauma and Orthopaedic Surgery (IITOS), the IHAI (representing most private hospitals) and the Irish Patients Association, to represent patients’ interests.

What did the incident management team do?

This team worked on all aspects of the recall, giving guidance to all hospital sites on how to identify patients, deciding on the clinical protocols for examining patients, arrangements for taking blood tests to a specific UK lab etc.  It was also responsible for all contact with DePuy and their nominated agents in Ireland.  This included working through all the financial and legal issues involved, in line with DePuy’s commitment to covering the costs of the recall process for patients and any remedial treatment that patients may need.

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Section 2 Initial Recall Appointments

Who had to attend for a recall appointment?

All patients who received one of these products had to be contacted and called for an appointment.

What did the recall appointment involve?

Taking on board expert advice from Orthopaedic Surgeons, Radiologists, a Chemical Pathologist and Public Health experts, it was decided that each patient would:

  • Be examined by their Orthopaedic Team. This was to see how they were, hear of any pain or other symptoms and conduct a clinical examination
  • Have a blood test. This was to measure the level of Chromium and Cobalt ions in the blood, which can give an indication that a metal implant may be wearing
  • Have an x-ray. This was to give a view of the implant in place, see how it appeared, and look for evidence of any wear or movement
  • Some patients also had MRI examinations

Where were the appointments held?

Most patients attended their original hospital, and their original surgeon, for the recall appointment.  Where patients preferred to attend a different site or clinician, this was facilitated where possible.

When did hospitals start recalling patients?

Hospitals began contacting patients by phone and letter in October 2010, either with pre-booked appointments or details of how to make an appointment.  This went on throughout November and December 2010 and early 2011.

What is the current situation?

At this point in time, all affected patients have been contacted by their hospital and the vast majority have already had their recall appointment.

What are the results of the first recall appointments?

While all patients are being looked after confidentially, we expect that for about 85 -90% of these patients, that is over 3,000 patients, no further immediate treatment will be required.  All patients who are without symptoms or problems will however be given an annual review appointment for a period of at least five years. 

Do patients have to pay for their recall appointment or treatment?

No. All medical care and treatment is being provided to patients by their hospital without any charge. For the initial recall appointment, this includes the clinic visit, the blood test and the x-ray.  It also includes the cost of transporting blood samples to a UK lab for testing.  Public and Private Hospitals will recoup all medical costs from DePuy.

What about non-medical costs that patients have?

Non-medical costs would include costs of:

  • Public or Private Travel to the recall appointment/follow up appointments
  • Necessary overnight accommodation costs
  • Cost due to time taken off work
  • Childcare costs etc.

To allow for this, DePuy have set up a separate facility for patients to apply for reimbursement of non-medical costs associated with the recall.  Patients who wish to apply for reimbursement of these types of costs can contact DePuy’s representatives for more information:

Aoife Travers, LCA Ltd., ( Thornton & Partners), Joyce Way, ParkWest, Dublin 12

Tel – 1800 937 999 or 01 4607700, Mon-Fri 8.00a.m. – 5.00 p.m.

All patients have been given a number  - a Unique Patient Idenitifer Code – that will make claiming expense more convenient. If you do not have your code, ask your hospital.

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Section 3 - Blood Tests and Metal Ions

Part of the initial recall appointment includes a blood test to measure levels of chromium and cobalt ions in the blood. 

Why was this blood test being done?

This blood test, measuring levels of chromium and cobalt ions in the blood, was done as part of a range of tests – clinical, x-ray, blood and for some, MRI – all of which together would give the surgeon a picture of how the implants were doing.  It was thought that this blood test would give to give an indication of any wear and tear of the implant, but only as one part of the overall assessment of the patient.

Why would there be Cobalt or Chromium ions in my blood?

All kinds of metal-on-metal or metal-on-plastic joint replacements would give rise to some metal ions in the system.  If there are some chromium or cobalt ions in the blood, this would be expected, as these are the metals that the implants are made of.  

Are these metals a health concern?

We don't have any information to say that either metal, in the form that is used in joint implants, is harmful.  In order to know the long term effects of any substance on a person, doctors and scientists need to carry out tests on large numbers of people, over a period of time.  There is very little evidence either in Ireland or internationally of

the impact of levels of these metals, and this will be the subject of ongoing future research. There is no evidence linking use of metal on metal implants to the development of cancer. (Tharani, Journal of Bone and Joint Surgery, 2001)

Are high metal ion levels unique to DePuy products?

No.  All metallic hip replacements from all manufacturers are expected to shed metal ions, with higher rates being expected in metal-on-metal systems.  The present recall was prompted by higher than expected failure rates of the ASR hip system when compared to other similar implants.

What does a high level of these metal ions in my result mean?

It could indicate some wearing of your implant, but your surgeon will assess these ion levels in conjunction with other investigations and discuss the best care option for you. However, if you are not experiencing pain or any other symptoms other than a raised Cobalt or Chromium level, the known risks of another surgery (like infection, complications of surgery etc) would have to be balanced against the unknown risks of the metal ion levels.  To know the long term implications, data will need to be gathered on large numbers of patients, and we expect more research to be done on this in Ireland and across the world in the future.

If a raised metal ion blood level is your only symptom, and you feel well otherwise, your surgeon will most likely recommend waiting for 3 months and repeating the blood test at that stage.

 It is important to remember that joint replacement surgery is carried out in order to alleviate significant and life-altering pain and discomfort.  The benefits of joint replacement surgery are well known to doctors and recipients, and are recognised as having almost unique capacity to transform quality of life for patients in severe pain.

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Section 4  - Treatment or Revision Surgery

How many people will need revision surgery?

A minority of patients – we expect about 12% or 450 patients based on UK data on these implants -  may require treatment or further surgery as part of this recall. This may be because of pain or other symptoms that indicate that the implant is wearing earlier that expected.  A small number of hospitals have already scheduled some of these revision surgeries.

Who will decide if a patient should have more surgery?

The patient and their surgeon will decide this, based on x-rays, examinations, blood tests, and the patient’s overall health.  It is important to weigh up the fact that any surgery, including a revision of a hip replacement, carries with it certain risk, like infection or complications of surgery. All patients and surgeons will have to balance these risks against any symptoms that may exist.

What if I need a revision surgery in the future?

It is possible that surgery is not necessary now, but may be recommended in a year, another time in the future.  DePuy have committed to covering the cost of any future revisions associated with this recall, so the same process outlined here will apply in the future.

What if I had my first surgery in one hospital, but I want to have the revision in another?

Some patients have requested this, particularly where their surgeon may have moved from public to wholly private practice.  It is possible to make a request to move hospitals or consultant through your hospital team, or through your GP if you prefer.

Will people who need surgery have to pay for it?

No. Patients can be assured that any further treatment or surgery that may be needed as a result of this recall will be provided to them without charge.  This applies whether the patient attends a HSE public hospital or a private hospital.  Hospitals who provide treatment to patients will apply to DePuy for reimbursement of all associated costs. This is in line with DePuy’s commitment to covering the costs of the recall process for patients and any remedial treatment that patients may need.

What about non-medical costs that patients have?

As before, the HSE and the relevant private hospitals can ensure that all medical and care costs are taken care of, but cannot assist patients with personal, non-medical costs related to this recall.

These would include costs like:

  • Public or Private Travel to the recall appointment/follow up appointments
  • Necessary overnight accommodation costs
  • Cost due to time taken off work
  • Childcare costs etc.

To allow for this, DePuy have set up a separate facility for patients to apply for reimbursement of non-medical costs associated with the recall.  Patients who wish to apply for reimbursement of these types of costs can contact DePuy’s representatives for more information:

Aoife Travers, LCA Ltd., ( Thornton & Partners), Joyce Way, ParkWest, Dublin 12

Tel – 1800 937 999 or 01 4607700, Mon-Fri 8.00a.m. – 5.00 p.m.

I have seen a consent form from DePuy for surgery – should I sign it?

DePuy originally suggested a consent form, which was on their website, which patients would sign prior to any revision surgery.  The HSE has negotiated with DePuy that this form IS NOT REQUIRED, either at this time or in the future.  Patients do not have to sign this consent form and may disregard it. 

What information will be given to DePuy?

Surgeons have agreed that instead of the proposed consent form, they will instead provide their personal assurance to the company that any revision surgeries arise out of this recall process and are appropriate.    Baseline anonymous data will be shared with the Irish Medicines Board and DePuy.  This will allow DePuy to confirm that the ASR system was used with appropriately matched components in each case.

As patients are aware, each person involved in this recall has been allocated a Unique Identifier Code which will allow their case to be tracked throughout the process.   This also allows the surgeon to confirm the case and the implant as a DePuy product, while preserving the patients’ anonymity.  If patients wish to make a claim to DePuy for non-medical expenses at a later stage, this Unique Identifier Code can be used in processing that claim – linking payment details to the anonymous records provided. 

Should I keep my DePuy implant after it is removed?

This information was updated on Oct 1 2011.

These types of hip implants are single-use devices, and are not intended to be re-used or removed, nor are they easily decontaminated or cleaned once removed.

Where a patient has to have a revision surgery, surgeons have confirmed that the act of removing the implant will almost certainly lead to it being damaged as it is removed.  Neither the HSE nor Private Hospitals require the DePuy implants for any future purpose. 

Patients who are having a revision surgery will be asked in advance to decide what will be done with their implant once it has been removed.  There are three options. 

  1. Send implant to London Implant Retrieval Centre (LIRC) for investigation.  The Irish Medicines Board have stated they require DePuy to investigate why the devices failed.  The LIRC have been commissioned by DePuy to carry out this investigation. The LIRC must first obtain the authority of the patient to do so.  Once this is provided LIRC will arrange for the transport decontamination, inspection, preservation and storage of the explant.  The LIRC will furnish a copy of the report of the inspection to the patient, to DePuy and to the Irish Medicines Board.  Ownership of the explant will remain at all times with the patient and it will not be released to DePuy without the express authority of the patient. LIRC will exercise its functions in a manner similar to protocols applied by Court Order to the testing of explants in the United States.  If you provide your authority to send the explant to LIRC the process will be funded in full by DePuy.
  2. Hospital Disposal: If you do not authorize  the sending the device to the London Implant Retrieval Centre,  the HSE or private hospitals can dispose of the device once it is removed, and will ask your authorisation do this. 
  3. Patient Custody:  Where patients wish to retain the implant themselves, you will be required to arrange the decontamination, transport and storage of the implant, at your own expense.

What follow up care will be needed after the surgery?

For routine cases, three review appointments will be scheduled after the revision surgery – at 6 weeks, 6 months and 1 year after surgery.  Again, patients will not be charged a fee for these appointments.

 

For more information:

If you have any questions about your care or this recall, the best place to start is your hospital.

Contact details should be provided on the covering letter posted to each patient during the week of May 23rd 2011.