Medical Device Recall Actions
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 |
Page last updated 16 April 2012