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Medsafe hip device statement | Scoop News.
Medsafe hip device statement
Wednesday, 3 October 2012, 4:14 pm
Press Release: Ministry of Health
Medsafe hip device statement
3 October 2012
An alert has gone out to surgeons in New Zealand implanting hip devices to advise that the Birmingham Hip Modular Head (BHMH) is no longer recommended for total hip replacement surgery.
Smith and Nephew, a UK company, says its Birmingham Hip Modular Head is not performing as well as expected when used in total hip replacement surgery.
NZ joint registry records show that of the 468 implants supplied to New Zealand, 396 have been registered for use in total hip replacements.
Metal-on-metal implants, including the BHMH, have only been used in 8% of the total hip implants during the last decade.
The implants affected to date represent less than 1.7 per cent of the nearly 71,000 hip replacements done in this country in the past 11 years.
This is the fourth worldwide action relating to the use of metal-on-metal implant components, starting with De Puy ASR in 2010 (525 devices in New Zealand), and earlier in this year, the Mitch TR (41), and the Smith and Nephew R3 (139).
Medsafe, New Zealand medicines and medical device regulator, says Smith and Nephew are contacting surgeons in New Zealand to notify them of this Alert and ask them to contact affected patients. Advice will include the need for greater monitoring of patients with these implants.
However Medsafe Group Manager Dr Stewart Jessamine says many patients with these implants and other metal-on-metal implants will not be affected by this or other alerts.
“The alert does not mean patients with the implant will necessarily require revision surgery, however, as a precaution patients with this implant will be followed up more frequently by their doctor.”
“If patients experience any discomfort or pain they should see their GP or surgeon as they normally would following any surgery on a joint.
Medsafe will follow-up with the NZ suppliers to ensure specialists have been contacted and patients notified.
Background
The Smith and Nephew Birmingham Hip Modular Heads were first used in NZ in 2005.
The Birmingham Hip Modular Head is a Metal on Metal (MoM) replacement system that consists of a Birmingham Acetabular cup, a conventional stem and a Birmingham modular head.
Smith and Nephew have issued this alert as joint registries in New Zealand, United Kingdom and Australian are all reporting these modular heads as having higher revision rates than for other orthopaedic implants.
The NZ overall revision rate of 1.51 revisions per 100 component years is comparable with the UK (1.29) and Australia (1.13) The slightly higher reporting rate for the NZ data is a consequence of the relatively small number of patients treated with this device in this country.
This action does not affect the Birmingham Hip Resurfacing implants which are performing to expectation.
There is a heightened awareness worldwide of possible higher revision rates in such devices.
Information about joint implants and revisions is collected by a register run by the New Zealand Orthopaedic Association: http://www.nzoa.org.nz
Information for consumers about metal-on-metal implants has been published on the Medsafe website at http://www.medsafe.govt.nz/profs/device-issues.asp#17April2012 and made available to surgeons.
Related articles
- Hundreds of faulty hip replacements (nzherald.co.nz)
- New Zealand – Medical Devices – Medsafe Guidelines for MoM hips (earlsview.com)
- Hip Resurfacing Draws Warning After Study Published in Lancet – NYTimes.com (earlsview.com)
- Smith & Nephew Ethics… (earlsview.com)
- GOT-CHA – Hips: Smith & Nephew issues failure warning on Birmingham metal-on-metal hips | MassDevice – Medical Device Industry News (earlsview.com)
- YAHOO – Smith & Nephew Birmingham Hip Lawsuit Filed Over Metal Poisoning – AboutLawsuits.com (earlsview.com)
- GOOD NEWS – Smith and Nephew sees a decline Birmingham hip implant business (earlsview.com)
- Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney (earlsview.com)
- Smith & Nephew Hip Replacement Lawsuit Filed Over Failed Liner – AboutLawsuits.com (earlsview.com)
- Warning issued about hip implant (radionz.co.nz)
Hi
My husband has 2 of the birmingham hip resurfacings. He had the 1st one done in sept 2009 and the other in november 2010. He has very high levels of colbalt and chromiun in his blood. He has been suffering from funny heartbeats, poor eyesight, skin itching with a rash and is really tired all the time. He has had these symptons for ages now and has had 2 heart tracings done plus various blood test which have come back normal. He has now been back to his consultant whio says he needs to have both these metal on metal hip joints removed and is going in hospital in the next 2 weeks to have revision on the left one as this is the worse out of the 2. Well its not even 2 years that he had the left one done and he and i are really concerned bout the damage this may have done to the bone as he has a lot of fluid built up around both of them. This is more common than there all letting on because we know 5 other people who have had the birmingham hip resurfacing and all of them have had revision or waiting to go in so this isn’t just the odd little failure like smith and nephew are trying to sweep under the carpet oh and whats worse is he’s got two of these so looks like he will be taking half a year off and this will be if there is no damage or the recovery could be a lot longer. Maybe smith and nephew would like to pay his mortgage because i don’t no how he’s going to.
HI Philippa
what a terrible situation – it was bad enough for me with only one hip to have revised to get rid of the S&N crap.
You husbands symptoms sounds like the ones I had too – almost from day one.
The one bonus is that he is going to feel so much better after the operations, even though he will have lots of pain and rehab to cope with. It will take a good 3 – 4 months to get mobile again depending on the bone grafts etc. But it is worth it.
I stopped feeling sick, the headaches went away, and I just feel much better than I had for years.
Now a year has passed and I am doing stuff I haven’t done for years – except when my left hip stops me – it needs replacing too.
All the very best,
Earl
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