Revised: 16 April 2012
Safety Information
Metal-on-Metal Hip Implants Timeline
Medsafe has compiled a detailed timeline beginning with the release of the DePuy ASR Resurfacing Hip System, through to the August 2010 recall action (hazard alert), and information issued by other medical device regulators since then.
| Date | Event | File Link |
|---|---|---|
| Jan-2003 | DePuy ASR products are granted CE Mark status, denoting compliance with European Medical Device Directive 93/42/EEC, approving the supply of these devices in the European Union. | |
| Oct-2003 | DePuy ASR products are approved by the Australian Therapeutic Goods Administration. | |
| Jan-2008 | DePuy ASR XL products (except resurfacing heads) are cleared by the US Food and Drug Administration for supply in the USA. | |
| Dec-2009 | DePuy withdraw the ASR and ASR XL products from the Australian and New Zealand market. Some product remains available for revision surgery. | |
| 04-Mar-2010 | DePuy circulate a safety notice to all implanting surgeons trained in the ASR that
higher than expected revision rates have been reported for ASR system with head sizes below 50mm in
diameter. DePuy reminded Surgeons of the importance of using the correct implanting technique for the ASR monoblock acetabular cup. |
DePuy ASR Notice (Adobe PDF document 92 KB) |
| 22-Apr-2010 | UK Medicines and Healthcare products Regulatory Agency (MHRA) issues a Medical
Device Alert (safety notice) MDA/2010/033 advising about potential complications in patients with
Metal-on-Metal hip implants. The Alert provides guidance to healthcare providers about the potential for soft tissue reactions around the joint and the management of patients. |
MDA/2010/033 (Adobe PDF document 180 KB) |
| 25-May-2010 | UK MHRA issues a Medical Device Alert (MDA/2010/044) advising physicians to ensure
ASR acetabular cups are implanted according to the manufacturer's instructions and that systems are
put in place to follow up patients with ASR cups implanted. This reinforces the information in the DePuy notice of 22-Apr-2010. |
MDA/2010/044 (Adobe PDF document 383 KB) |
| 24-Aug-2010 | DePuy contacts Medsafe proposing to distribute a recall notice (hazard alert) to all
ASR trained surgeons in New Zealand advising them that new data from the UK National Joint Registry
shows revision rates of 13% for ASR hips. The notice advises surgeons on how to follow-up with patients. Revision (replacement) surgery is only recommended where there is evidence that the patient's joint is failing. |
DePuy Hazard Alert (Adobe PDF document 127 KB) |
| 25-Aug-2010 | Medsafe agrees to the distribution of the notice to physicians. | |
| 27-Aug-2010 | DePuy provides Medsafe with copy of a Recall notice issued in the USA and UK for the ASR system. | DePuy USA Recall Notice (Adobe PDF document 94 KB) |
| 07-Sep-2010 | UK MHRA issues a further Medical Device Alert (MDA/2010/069), replacing the earlier
MDA/2010/044 notice. This MDA was issued in response to the DePuy recall notice and instructs surgeons to not perform any further ASR implants, to return all unused implants to DePuy, and to inform all patients about the recall. |
MDA/2010/069 (Adobe PDF document 394 KB) |
| 01-Oct-2010 | DePuy contacts Medsafe proposing to distribute additional information to orthopaedic
surgeons including; Sample patient letter Patient information sheet ASR Hazard Alert Reference Guide for Healthcare professionals Patient consent form for disclosure of records The letter to patients 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. |
DePuy ASR Patient Information Sheet (Microsoft Word document 46 KB) DePuy ASR Sample Patient Letter (Microsoft Word document 20 KB) DePuy ASR Reference Guide (Microsoft Word document 30 KB) |
| 06-Oct-2010 | Medsafe agrees to the distribution of the notices to surgeons, noting that as the collected patient data is going outside of New Zealand that DePuy obtain the opinion of ethics committee if this had not already been done. | |
| 10-Oct-2010 | The ASR situation is reviewed at the Orthopaedic Association Annual Scientific Meeting in Adelaide, Australia. | |
| 10-Feb-2011 | US Food and Drug Administration (US-FDA) issue advice to orthopaedic surgeons about
metal-on-metal implant surgery and patient management. This advice includes information about responding to localised symptoms, metal ion testing, and joint revision (replacement). |
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ ImplantsandProsthetics/MetalonMetalHipImplants/ucm241667.htm |
| March 2011 | British Orthopaedic Association Annual Conference discusses large diameter Metal-on-Metal hip implants. The Association issues a notice agreeing with the patient management information issued by the MHRA applies. | BOA Notice - March 2011 (Adobe PDF document 65 KB) |
| 16-May-2011 | Australian Therapeutic Goods Administration (TGA) issues notice about the Australian experience of the ASR system. | http://www.tga.gov.au/newsroom/btn-dupuy-recall.htm |
| June 2011 | New Zealand Orthopaedic Association issues statement regarding the withdrawal of ASR devices noting that all surgeons had been advised. | NZOA Statement (Adobe PDF document 54 KB) |
| November 2011 | Release of Australian Senate Community Affairs References Committee report into "The regulatory standards for the approval of medical devices in Australia" which includes a large section on the DePuy ASR hip system. | Australian Senate Report (Adobe PDF document 1541 KB) |
| 29-Jan-2012 | UK media (The Telegraph) announce that situation regarding ASR hip implants is worse
than originally believed and that MHRA is preparing new advice regarding patient management. This story is picked up in New Zealand on 30/31-Jan-2012. |
http://www.telegraph.co.uk/health/9047087/Health-warning-over-hip-implants.html |
| 30-Jan-2012 | Medsafe contacts all known suppliers of orthopaedic implants in New Zealand requesting information about number of hip implants and whether they have supplied Metal-on-Metal implants here. 20 potential suppliers contacted; 9 have supplied Metal-on-Metal implants in NZ (5 are currently supplying). A total of 6,225 Metal-on-Metal implants supplied in New Zealand since Sep-2000. | |
| 28-Feb-2012 | UK MHRA issues updated information (MDA/2012/008) replacing previous advice issued
(MDA/2010/033 and MDA/2010/069). The notice describes recommended follow-up period and types of patient testing to be conducted as part of the monitoring process. |
MDA/2012/008 (Adobe PDF document 634 KB) Press Release (Adobe PDF document 57 KB) |
| 29-Feb-2012 | British Medical Journal (BMJ) and BBC release article about potential long-term problems with large head Metal-on-Metal hip implants. | http://www.bmj.com/content/344/bmj.e1410 |
| 01-Mar-2012 | British Hip Society (BHS) endorses guidance issued by MHRA on 28-Feb-2012. BHS advises that Metal-on-Metal hips using bearings (cups) of 36mm or above should no longer be performed. | BHS Statement (Adobe PDF document 403 KB) |
| 04-Apr-2012 | British Medical Journal (BMJ) releases results of the risk of cancer in the first
seven years after metal-on-metal hip replacement. It concluded that there was no evidence that metal-on-metal hips were associated with an increased risk of any cancer diagnosis in the seven years following surgery. |
http://www.bmj.com/content/344/bmj.e2383 |
