Earl's View » Biomet Hip Replacement

Biomet Issues Addressed at FDA Meeting

aquering — Wed, 03 Oct 2012 17:58:21 +0000

Two representatives for Biomet’s metal-on-metal hip replacement products may have avoided talking about some serious issues at an FDA meeting earlier this summer. While they claimed that Biomet is safer than other metal-on-metal hip implants because they contain less cobalt-chrome, research has found high titanium levels in Biomet hip implant patients. Biomet’s presentation also focused on their M2a-Magnum device when registry data shows a significantly higher revision rate with a different Biomet device.

Dave Schroeder of the Research Department at Biomet explained how the M2a-Magnum design minimizes “edge loading,” or the chisel-like effect that occurs when the ball grinds against the socket and sheds metal debris into a person’s bloodstream. Instead, he blamed edge loading on patients’ individual bodies and doctors’ placement of the device. Dr. Jing Xie, in charge of Biomet’s Global Clinical Research, followed up with praise for the device because of its lower cobalt-chrome levels in patients’ blood samples. She explained that the Biomet “M2a-Magnum has the lowest cobalt level” in follow-up research, most likely due to its “unique design of adapter sleeve, which is made of titanium.” However, Dr. Xie did not mention the high levels of titanium found in patients’ bodies which can also lead to hip replacement failure.

To find out more about the Biomet presentation, read the full article at PA Law Blogs.

Filed under: Biomet, Biomet Hip Replacement, Biomet Magnum Hip Tagged: Biomet Hip Replacement, biomet hip replacement failure, Biomet Magnum Hip

USA – Terry Speaks from His Personal Hell re BioMet Magnum M2A

earlstevens58 — Fri, 27 Jul 2012 04:27:46 +0000

Be very vigilant and alert with your health if you have a metal on metal device. I had written before about my plight with a BioMet Magnum M2A that was put in me at 57, over 5 years ago.

I had a couple of years with some discomfort and was told more therapy! I kept trying to tell the doctors I was healthy as a horse prior to having this THR.

Three years ago it continued to get worse and walking through a grocery store even became a big problem. Then insomnia and panic attacks started and when they hit, I felt I couldn’t breath. It was almost terrifying because you couldn’t even lay down and sleep. Xanax helped. However the actual breathing started becoming a real problem. Then the hip actually dislocated on a few occasions and the pain was unbearable.

I now have three levels of hip pain. A level three where it feels swollen and a grease job would help. A level 5/6 where I am convinced the head is not 100% in the socket, it almost feels like it’s cutting me inside but I can limp around with a cane. Then 4 occasions of what I believe is total dislocation and it is nearly ambulance calling pain. However if I immediately sit and endure, with tears, it does seem to revert back into the socket. Sleeping on my right side with foam padding seems to push the device back together and the next day becomes a crap shoot.

The original surgeon abandon me when bone scan, x-ray and blood test did not indicate a problem.

A second Orthopedic surgeon decided it was muscle and ligament via MRI and I endured multiple injections in the hip. He gave up also. This was at a renowned Orthopedic Clinic in the Denver metro area!

In May 2012 I went to University Hospital and they wanted heart and pulmonary evaluation before committing to revision surgery. I was very angry as I just wanted the thing out of me. However they saved my life requiring those tests. The heart was enlarged on right side which pointed to lung issues. A CT Scan of the lungs showed I was full of blood clots. I was in critical care for a while until they could evaluate and get me on Heparin and Coumadin.

They think the blood clots started shortly after the original surgery as they appeared to be older. They kept insisting I had to have been in severe pain when these happened. That just never happened in the five years so they are just guessing when they occurred.

I now may be on Coumadin the rest of my life! Needless to say nobody will do anything until the clots recede or go away and that may mean years of Warfarin. I just hope and pray that this piece of crap BioMet isn’t destroying my right leg in the mean while.

So despite the information about MoM failures and the comment I had seen about health issues seemingly unrelated to your MoM device, make sure your doctor investigates all of your symptoms individually. I kept believing the breathing issues were because of the effort to just move my right leg to walk. I had my mind made up if I got a revision that everything else would magically go away!

With the FDA making a bad decision to allow these MoM devices in the first place and now giving no direction to recall or definitive direction to the medical community, you are essentially on your own to find a surgeon that will clean up the mess. I can’t blame any of them when a potential lawsuit looms that may drag them in. Bottom line: I’m grateful to be alive, but life ain’t a bowel of cherries!

Terry in Colorado

DJ Carey shock after brain surgery for blood clots (independent.ie)
Biomet M2a Magnum device – Multidistrict Consolidation Sought (earlsview.com)
Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit (earlsview.com)
FAQ: When will my clot and pain go away? (patientblog.clotconnect.org)
Aspirin May Prevent Recurrence of Deep Vein Blood Clots (news.health.com)
Palladino: Clot Not End Of World For Dillon Gee (newyork.cbslocal.com)
New scare for DJ as blood clots found in his brain (independent.ie)
Doctors expect savagely beaten man to survive (miamiherald.com)
Blood Clot Puts Mets’ Gee on Disabled List (nytimes.com)
Mets: Gee’s Replacement Needs to be Harvey (ballhyped.com)

Filed under: Biomet, Biomet Hip Lawsuit, Biomet Hip Replacement, Biomet Magnum Hip, cobalt, Cobalt chrome, Cobalt Poisoning, Metal on metal hip, metal on metal hips, Metallosis Tagged: Biomet, Colorado, Denver, denver metro area, Food & Drug Administration, Health, heparin, Medicine, Orthopedic, scan x, Thrombus, warfarin

Biomet M 2 a Hip Implants | Defect Hip Implant Lawyers

earlstevens58 — Mon, 16 Jul 2012 11:22:25 +0000

Biomet M 2 a Hip Implants | Defect Hip Implant Lawyers.

Biomet M 2 a Hip Implants

Biomet Orthopedics started its M 2 a line of versatile hip implant devices in 1996, and currently, the manufacturer produces six varieties of M 2 a metal ball components. Hip implant systems, such as the ones made by Biomet, are comprised of three components – a ball, a cup-like device inside which the ball fits and rotates, and a stem connected to the ball that also connects to the thigh bone.

The six types of metal ball components that make up the M 2 a line include:

M 2 a-RingLoc™, introduced in May 1996
28mm M 2 a-Taper™, introduced in May 2000
32mm M 2 a-Taper™, introduced in September 2000
M 2 a-30™, introduced in November 2001
M 2 a-Magnum™, introduced in October 2004
M 2 a-Magnum™ Tri-Spike™, introduced in February 2006

While all of these M 2 a hip implant components are made of a metal alloy (that contains some combination of Cobalt, Chromium and Molybdenum), they differ in size, range of motion, and how they connect/interact with the other components of Biomet hip implant devices.

Design Features of Biomet M 2 a Hip Implant Devices

With more than 15 years of experience in manufacturing hip replacement devices, Biomet prides itself implementing the latest technologies and newest innovations — including use of cutting-edge alloys, improvements to the shape and fit of components, and surgical innovations and techniques — in order to:

Maximize mobility
Minimize friction between the devices’ metal components
Minimize the possibility of hip dislocation (due to the ball popping out of the cup component)
Reduce pain
Increase the longevity of the device and, consequently, minimize the possible need for future revision surgery

Individuals most likely to need a Biomet M 2 a hip device include those who have not been able to successfully treat or manage the severe symptoms associated with osteoarthritis, bone tumors, and/or hip fractures. Typically, other, less invasive treatments, such as physical therapy and medications, are tried before a Biomet M 2 a device is surgically implanted in patients.

Design Flaws of Biomet M 2 a Hip Replacement Systems

Despite use of certain innovations, Biomet M 2 a hip devices carry some risk of malfunction, depending on a patient’s medical history, the surgical method used to implant the device, and the patient’s lifestyle (i.e., whether the patient lives a more active or a more sedentary lifestyle).

Some of the possible design elements that can put patients at risk of needing one or more revision surgeries include:

Allergic reaction to the device
Damage to the bone, tissues, and/or nerves surrounding the device (due to implantation methods or the size and nature of the implanted device)
Loosening of the device, which can contribute to hip dislocation
Shape and fit of the ball and cup components, as those with more active lifestyles may move in ways that causes dislocation of the device
Shortening of the leg attached to the device, due to an improper fit of the Biomet M 2 a
Use of metal components, as they have the potential to grid on each other, causing metal ions to be released into the blood (this can cause inflammation in the surrounding tissue and bone; long term effects can include heart and neurological damage)

Contact a Defective Hip Lawyer

If you or someone you love has had problems with a hip replacement, you might be eligible for compensation. To learn more, schedule a free case review with an experience defective hip implant lawyer today.

About Metal-on-Metal Hip Implants (earlsview.com)
Smith And Nephew Hip Replacement Recall Lawsuit Attorney (earlsview.com)
Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit (earlsview.com)
Biomet Hip Lawsuit – Biomet Magnum Hip Implant (earlsview.com)
Stryker Recalls Two Metal-on-Metal Hip Implants (earlsview.com)
US Drug Watchdog Now Calls All Metal Hip Implant Failures the Biggest Disaster Ever (earlsview.com)
Long-Term Health Risks Associated with Genotoxic Nanoparticles Released by Failing Metal-on-Metal Hip Implants (earlsview.com)
STRYKER REJUVENATE HIP IMPLANT RECALLED | West Palm Beach Personal Injury Attorneys Blog (earlsview.com)
FDA Reports16,800 Metal On Metal Hip Implant Adverse Events (earlsview.com)
FiDA Failed Implant Device Alliance (earlsview.com)

Filed under: Biomet, Biomet Hip Lawsuit, Biomet Hip Replacement, Biomet Magnum Hip, Metal on metal hip, Metallosis Tagged: Biomet, DePuy, Food & Drug Administration, gaming, Health, hip dislocation, Hip Replacement, Limited liability partnership, Medicine, metal, science, surgery, Technology, UNited States

What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs

earlstevens58 — Fri, 23 Mar 2012 23:51:26 +0000

What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs.

What is the Status of Biomet Metal on Metal Hip Replacements

As of February 2012 Biomet M2a-Magnum Metal-on-Metal Hip replacement (Biomet hip replacement) has not been recalled. Yet, the absence of a medical device recall does not mean that patients and surgeons should accept a product’s safety without further examination.

Biomet Hip Replacement Has Similarities to Other Metal on Metal Hip Replacements

The FDA is currently reviewing the safety and effectiveness of all metal on metal hip replacements. As with other manufacturers’ metal on metal hip replacements, Biomet MoM devices work with metal balls that moves against metal cups. While metal on metal devices were designed to improve wear and extend the life of a hip replacement device, there is some concern that metal on metal hip replacements may fail earlier than other types of hip replacements and put patients’ health at risk.

Concerns About Biomet Hip Replacements Have Been Raised

The safety of metal-on-metal hip replacement by Biomet has been questioned. The number of adverse reports concerning Biomet hip replacements has increased over the past few years. Additionally, lawsuits have been filed alleging that these metal on metal hip replacements are prematurely failing and putting patients in pain and/or at risk.

While the FDA and others continue to investigate the safety of Biomet hip replacements, and other types of metal on metal hip replacements, it is important to talk to your surgeon about the device that is right for you and about what to do if you experience any complications.

March 20, 2012 in Medical Device Updates

Howard Sadwin’s Suffering from Metal-on-Metal Hip Implant | Mesh Medical Device Newsdesk (earlsview.com)
BBC News – Surgeons call for end to metal hip replacements (earlsview.com)
Study prompts call for wider ban on metal hips | Reuters (earlsview.com)
All-Metal Hip Replacements: Not All Patients Informed of Recall | Qmed (earlsview.com)
Press release: MHRA updates advice for metal-on-metal hip replacements : MHRA (earlsview.com)
Novel – Dual Pivot Hip | Hip Replacement, Total Hip Replacement | Total Joint Joint (earlsview.com)
Tens of thousands of British patients with metal hip replacements at risk of being poisoned (earlsview.com)
Hip patients: Why weren’t we told? – National – NZ Herald News (earlsview.com)
Biomet Magnum Horror Story – Stacey’s View (earlsview.com)
Metal-on-Metal Hip Implants > Concerns about Metal-on-Metal Hip Implant Systems (earlsview.com)

Filed under: Biomet, Biomet Hip Lawsuit, Biomet Hip Replacement Tagged: Biomet, DePuy, FDA, Food & Drug Administration, Hip Replacement, Medical device, Medicines and Healthcare products Regulatory Agency, Patient

The Power of the Birmingham Hip Resurfacing – NOT

earlstevens58 — Sat, 21 Jan 2012 07:34:10 +0000

Howard Sadwin – robbed of life

Many of you will have read Howard Sadwin’s story and comments over the last 6 months.

If you have any doubt about the impact of the BHR hip replacement device when it goes wrong – which is being seen more and more – then take a look at this. Same goes for other Metal on Metal hips.

Howard used to enjoy taking on the world and time with his Grandson - now his wee boy wants to do other things but the roles are reversed.

Howard suggests that all of you who have had problems with any hips - to take videos, pictures of how your MOM has altered your life, moving around, can’t bend over, can’t walk whatever. I will publish them – over 86,000 visits to this site in the last 6 months – nearly 800 a day at present – your story will get heard.

You can email me at earl.stevens@gmail.com

Birmingham surgeon the hero as Iron Mike gets metal hip | Easier (earlsview.com)
Another S&N BHR goes Sour – Brenda’s Story (UK) (earlsview.com)
Katie’s Full Story – Metal on Metal BHR Mess (earlsview.com)
A comparison of Leg Length and Femoral Offset discrepancies in Hip Resurfacing, Large Head Metal-on-Metal and Conventional Total Hip Replacement (earlsview.com)
Jill’s View – Happy New Year! (earlsview.com)
Hip Resurfacing – Hip Surgery Option Loses Key Backer (NY Times) (earlsview.com)
JBJS | A Multinational Assessment of Metal-on-Metal Bearings in Hip Replacement (earlsview.com)
More Hocus Pocus around the Smith & Nephew BHR Metallosis Problems (earlsview.com)
AAOS Releases TO on MoM Hip Implants (earlsview.com)
UK surgeon warns public about dangers of all-metal hip implants, especially for women | Depuy Hip Recall (earlsview.com)

Filed under: Arthritis, Baby Boomers, Biomet Hip Lawsuit, Biomet Hip Replacement, Birmingham Hip Resurfacing, Bone & Joint Health, Bone Loss, Chrome Poisoning, Cobalt chrome, Cobalt Poisoning, Depression, DePuy, DePuy ASR Hip, DePuy Hip Litigation, DePuy Hip Replacement, DePuy Lawsuit, DePuy Pinnacle Hip Replacement System, FDA, FDA 510k process, FDA Recall, hip implants, Hip loosening, Hip recall, Hip Replacement, Hip Resurfacing, Hip Revisions, hip surgery, Infection, Johnson & Johnson, Johnson & Johnson lawsuit, Joint replacement, leg length, Metal on metal hip, Metallosis, metallosis, muscle cells, Nerve damage, Osteoarthritis, Osteoarthritis Pain, Pain Management, Rehabilitation, risk of infection, Smith & Nephew, Smith & Nephew BHR Problems, Total Hip Replacement Tagged: Birmingham Hip Resurfacing, Cobalt chrome, cobalt levels, Cobalt poisoning, DePuy, Food & Drug Administration, Hip Replacement, hip resurfacing, Howard Sadwin, Medical device, Nephew Smith, Smith & Nephew, Smith & Nephew BHR Problems, UNited States

Biomet Magnum Horror Story – Stacey’s View

earlstevens58 — Thu, 05 Jan 2012 21:44:27 +0000

Stacey‘s Story

Just found your Blog and have to answer “Is there some good news amongst the bad” and the answer is a resounding NO.

My Biomet Magnum has caused horrific complications from metallosis.

My chromium was 20 and cobalt was 17.

Both were many times higher than the accepted rate, and my symptoms are severe, even after a revision.

I have numerous problem with the hip but the vision and hearing changes continue to worsen.

Please don’t think this is an acceptable device, and please don’t let your readers think it’s what they should have put in.

It’s hell to live with and I probably can’t have another revision, so my problems with the Biomet will be ongoing for life.

I am 50 yrs old and that stinks!

Jackie – a typical story repeats again & again – Patient Fear and Distress (earlsview.com)

Filed under: Biomet, Biomet Hip Replacement, Biomet Magnum Hip, cobalt, Cobalt chrome, Cobalt Poisoning, Cobaltism, Hip Replacement, Joint replacement, metal on metal hips, Metallosis Tagged: Alternative, Biomet, Health, New Year, Southern California, Stacey, Stacey Slater, UNited States

Jackie – Part Two

earlstevens58 — Wed, 28 Dec 2011 22:23:07 +0000

Comment from Jackie:

I HAVE TO AGREE WITH THIS AND NOT ONLY WITH ZIMMER OR JUST KNEES, WITH ANY METAL ON METAL DEVICE THAT IS PUT INOT OUR BODIES BECAUSE….THIS PROBLEM WITH COLBALT AND CHROMEUM STARTED WAY BEFORE MY REPLACEMENT IN MARCH, 2010, SO MY QUESTION IS…WHY ON EARTH WOULD THESE COMPANIES CONTINUE TO USE THESE KNOWING FULL WELL OF THE PROBBABLE OUTCOME.

SO HERE YOU ARE, I AM AND MANY MANY OTHER ARE WITH LEVELS OF METALS IN OUR BLOODSTREAM THAT DO NOT BELONG, WHY ARE THEY STILL ALLOWED TO CONTINUE TO POSION US AND MAKE OUR PAIN WORSE THAN IT WAS BEFORE WE DID THIS BECAUSE OF THE FAILURE RATE??

THESE COMPANIES ALL NEED TO BE STOPPED FROM MAKING REPACEMENTS WITH THESE THINGS IN IT. WE HAVE ALL GONE IN THINKING WE WHERE GOING TO BE BETTER OFF AND GETTING SO MUCH BETTER AND WE ARE WORSE OFF THAN WE EVER WERE.

SO NOW WHAT ARE WE GOING TO DO ABOUT CHANGING THIS?? I AM OPEN TO ANYTHING THAT WILL STOP THIS FROM CONTINUING TO HAPPEN TO MANY MANY OTHERS, AND AGAIN ITS ALOT OF DIFFERENT MANUFACTURS. ANY THOUGHTS OR IDEAS??

My View:

Hi Jackie

the problem is that medical science is not ever 100% and for between 85% and 95% of the population metal on metal, except for DePuy ASR’s, have been working (failing) at an “acceptable level”.

We unfortunately are part of the smaller percentage where they do not work.

Given the overall problems with metal on metal and their tendency to wear excessively and cause problems when not fitted well, it is likely that metal on metal will be phased out rather quickly and replaced with ceramic on ceramic or other combinations like metal on plastic. Even these combinations have their issues. Plastic wears and can cause osteolysis – this is well documented – even pseudotumours but there are not the problems with metal toxicity that occur with metal on metal.

The thousands of lawsuits before the courts at present have sent a loud signal to the manufacturers – you will see changes – but there will always be problems with hip replacements for some of us, depending on our anatomy and physiology – this is just the result of us being a biological soup. Nothing is perfect, sadly.

Earl

Financial toll soars for hip implant failures – KansasCity.com (earlsview.com)
Jackie – a typical story repeats again & again – Patient Fear and Distress (earlsview.com)
UK surgeon warns public about dangers of all-metal hip implants, especially for women | Depuy Hip Recall (earlsview.com)
US Drug Watchdog Urges All ASR DePuy Hip Implant Recipients to Get Identified and Lists the Most Common Symptoms of a Hip Implant Failure (earlsview.com)
Will Flawed All-Metal Hip Replacements Cost J&J and Zimmer $5 Billion? (forbes.com)
Failing hip implants will cost billions to replace (seattletimes.nwsource.com)
Recalled DePuy ASR Hip Implant Lawsuits Filed By The Law Offices Of John David Hart – TheStreet (earlsview.com)
New Data On Skyrocketing Hip Failure Rates Echoed In Bernstein Liebhard LLP’s Clients (prweb.com)
DePuy Hip Recall | Pinnacle Hip Recall News (earlsview.com)
Zimmer knee replacement manufacturer sued for metal on metal design | Louisiana Record (earlsview.com)

Filed under: Arthritis, Biomet, Biomet Hip Lawsuit, Biomet Hip Replacement, Birmingham Hip Resurfacing, Bone & Joint Health, Hip Replacement Tagged: DePuy, Earl, Failure rate, Hip Replacement, Johnson, Medicine, UNited States, Zimmer Holdings

Jackie – a typical story repeats again & again – Patient Fear and Distress

earlstevens58 — Tue, 27 Dec 2011 22:15:29 +0000

Comment received on Earlsview Blog this morning

I’m not sure if i am posting this in the right place but here goes.

I have a Biomet metal on metal LHR, I got this done in march, 2009 and have been having lots of problems like grinding feeling when I try to bend my leg a tiny bit, and my cobalt level is 6.4 and chromium is 3.6 which is elevated.

About 2 weeks ago I started feeling a dull ache in my hip that is very bothersome and then over the holiday while at home, the ache got worse, and I starting having a stabbing pain in my hip socket area, it hurt so bad and i was so scared that I could not breath.

I stood by my bed and changed into my PJ’s and laid down, on my good side and cried myself to sleep. I really thought I would end up in the ER, but the next morning I felt better as far as the stabbing pain, its still light and the ache is still there but i have been staying off of it.

What is going on?? Has anyone had this problem?

My new ortho specialist is aware of all but what happen with the dull ache and stabbing pain.

I was better before my surgery…..I’m only 46, 44 when I had the surgery and I am lost.

If you have any knowledge or thoughts to share please do………..maybe it will help me not be so stressed and scared

My View:

your story is very like mine except I had a Smith and Nephew RHR (THR) metal on metal. I was 50 and 53 years old when I had my hip done and then revised.

Your body is telling you that it is being damaged – the elevated chromium and cobalt is evidence for a blind man that suggests that your hip prosthesis has been out of alignment and wearing and producing metal wear particles – which will be destroying your bone and surrounding tissue – hence the pain. Possibly one part of it is loose if you have the grinding?

These sort of problems occur with all types of metal on metal when they don’t fit properly. In my case, my hips are slightly displaysic and so the surgeon did not compensate when he fitted the hip, I suspect.

You are right – it feels worse than the arthritis before you had the hip replaced. Exactly what I though.

The only way to fix this is to get a hip revision – I can happily testify to the effectiveness of a Zimmer revision system – ceramic on ceramic – my bone grafts have taken well and I have lots of new bone growth – instead of the bone and tissue death I was getting with the S&N Birmingham Spectron MoM THR.

If your current surgeon won’t do anything, ditch him and find an honest one who will admit to the problems everyone is having – and get it replaced.

For some reason, many surgeons seem to think “holding rank” and not criticizing their colleagues is more important than patient health. Check whether he is receiving payments from the orthopaedic device companies and is morally compromised.

Whatever you do – don’t worry, there is a very simple solution and the relief you will feel when you get it out is fantastic! I know!

Earl

UK surgeon warns public about dangers of all-metal hip implants, especially for women | Depuy Hip Recall (earlsview.com)
New report highlights metal hip implant problems | Reuters (earlsview.com)
Watch out for Doctors who Ignore the Facts – Trust your Body – it is more sensitive than X-Rays! (earlsview.com)
BHR Metallosis – Trust your Body – it is more sensitive than X-Rays! (earlsview.com)
Further Patient Problems – in response to NY Times Article (earlsview.com)
Total hip replacement for high dislocated hips without femoral shortening osteotomy: (earlsview.com)
Why do surgeons avoid the obvious when patients complain??? (earlsview.com)
Aspiration Revealed My ASR Device Had Failed While Other Diagnostic Tests Were Still Reading “Normal” (earlsview.com)
DePuy ASR NOT Safe – Aspiration Revealed My ASR Device Had Failed While Other Diagnostic Tests Were Still Reading “Normal” (earlsview.com)
Hip Implants – from American Academy of Orthopaedic Surgeons (earlsview.com)
Rise above the ‘opioid wars’ to manage chronic pain (seattletimes.nwsource.com)

Filed under: Arthritis, Biomet, Biomet Hip Lawsuit, Biomet Hip Replacement, Bone growth, Bone Loss Tagged: Acetabulum, Biomet, Earl, Hip Replacement, pain, Smith, Smith & Nephew, Zimmer Holdings

McMinn Centre Data Suggests How Bad DePuy ASR was v. Others on the Market

earlstevens58 — Tue, 26 Jul 2011 11:06:27 +0000

Response to Channel 4′s ‘Dispatches’ Program

The Dispatches program ‘Going Under the Knife’ aired on the 16th of May 2011 and ‘The One Show‘ program aired on the 24th of May 2011 raise two or three important questions.

Joseph Daniel FRCS MS(Orth)
Staff Surgeon & Director of Research

Source: http://www.mcminncentre.co.uk/response-dispatches-program.html

TV Programs ‘Dispatches’ and ‘The One Show’ highlighted failures with ASR resurfacings. Do these apply to the BHR as well?

These TV programs did a good job of bringing to attention the sad saga of failures with the ASR hip. Although the experience of only one Centre was highlighted, this experience with ASR failures is widespread. What the programs did not show was the experience of the same Centre with Birmingham Hip Resurfacings (BHR). Their data in the figure below clearly shows that wear-related failures with the BHR are extremely low (1.3%) and that failures are highly implant specific. BHR is now being used in their Centre again.

In comparison to the appalling 7-year results of the ASR, several large series from around the world published 8 to 13 years after BHR introduction confirm a low failure rate from metal debris reactions. The majority of cases in these series were BHRs.

When I received my hip resurfacing, was I treated as a guinea pig or was there sufficient testing beforehand?

There is a perception that all metal-on-metal (MoM) resurfacing devices have been introduced into clinical usage without much thought or testing. That is true for many recently introduced resurfacings, but not true for the BHR.

It is 3 months since we at the McMinn Centre celebrated the 20th anniversary of the first modern MoM resurfacing. Since then we have reviewed several patients for their 20-year follow-up and some of those early devices are still functioning well.

Mr McMinn obtained some of the successful metal components and had them carefully analyzed. Their beneficial design features and materials were incorporated into my earliest concept models. After further tests we implanted the first modern metal-on-metal (MoM) resurfacing in February 1991.

During the next six years we conducted several studies to assess the viability of the femoral head after resurfacing, to determine the best method of fixation of the implants and the effects of metal wear. Further potential problems with the design and material processing of these devices were meticulously identified and addressed in subsequent models, until the introduction of the Birmingham Hip Resurfacing (BHR) in 1997 as a product based on the many lessons learnt during those years.

From 1991 to 1997 the device had largely been used by a few of us hip surgeons in Birmingham and not released for general usage. We had worked on the device in Birmingham for over 6 years and perfected it in a steady step-wise manner before releasing it for general use

After the BHR was introduced, a training program was instituted for surgeons and further studies were started. These relate to hip function, metal ions, implant migration, stress shielding, the effects of resurfacing and replacement on the coagulation cascade and the best form of thromboprophylaxis, to name a few.

As the years passed, patients and surgical colleagues saw the outstanding results in young and active patients and overcame the initial scepticism relating to the potential problems with MoM. Till then patients undergoing hip replacements were almost universally advised to give up high activity in order to allow the hips to last. With the BHR, patients were advised to carry on activity as normal. The operation not only restored hips to a pain-free status but allowed some of the patients to return to phenomenally high activity levels and regain their lost dreams and goals in life, including world championships in some cases, even in certain high impact sports.

I have had a Birmingham Hip Resurfacing (BHR) a few years ago. Other than the odd stiffness and ache I do not experience any symptoms. Do I need metal ion testing?

We have tested hundreds of patients with one-sided and two-sided resurfacings and hip replacements. Of the first 350 BHRs we tested all those who could attend a review and provide blood for testing at their 10 year review. There have been no alarming metal ion levels that could cause concern in any. The metal ion levels are in the order of a few parts per billion and at these low levels testing can be tricky. Undertaking these tests at any local laboratory can lead to misleading conclusions. Experts agree that routine metal ion testing is not required except in devices such as the ASR or in very badly positioned components. With a proven resurfacing like the BHR when it is implanted in a good position the wear from the bearing is very low and the prospect of long-term success is high.

What are the current results of the BHR in the National Joint Registers?

The Australian and the UK National Joint Registers together comprise the largest unbiased documentation of artificial joint devices in the world. The BHR has the longest follow-up and the largest number of resurfacing cases included in both these Registers. Both these Registers show that BHRs are performing better than the national guideline for excellence in hip replacements.

What then are the options for a young patient with hip arthritis? Are non-metal-on-metal (non-MOM) hip replacements safer than metal-on-metal (MoM) hip resurfacings?

The reason for our introduction of MoM resurfacings in young patients was because the failure rates of traditional hip replacements in the young were very high. The Swedish Register showed that in men with osteoarthritis under the age of 55 years, traditional hip replacements failed at the alarmingly high rate of 19% at 10 years and 67% at 16 years. This is worse than the revision rate of all resurfacings combined and much worse than the revision rates of the BHR in the UK and Australian Registers. These traditional hip failures were associated with much bone loss and progressively difficult revision operations. Our failure rate with the BHR in the same age group and diagnosis is 2% at 13 years.

There are no easy solutions for the young patient. With traditional hip replacements, the problems of multiple revisions and of multiple dislocations in active young patients can be very restrictive for a patient wanting to resume an active lifestyle.

Furthermore every hip device whether using a polyethylene bearing or a ceramic bearing has metal in the stem and/or in the cup. It is just coming to light that with non-MoM hips also can leech metal from the (taper) joint connecting the stem and the head (or the cup and the insert) and cause the same problems as seen with bad resurfacings.

What has shocked many in the orthopaedic community is a hitherto unidentified finding in the UK National Register that the mortality rate 5 years following hip resurfacing is phenomenally lower (1.8%) compared to that following hip replacements (9.9%). This benefit persists even after adjustment for age, gender and physical status. This suggests that traditional hip replacement adds some as yet unidentified detrimental effect to the patient as a whole, which the recipients of hip resurfacing appear to escape.

SUMMARY

Total hip replacement in young patients comes with the price tag of a higher revision rate and a higher mortality rate. A well-designed, well-engineered, well-implanted resurfacing is a much better option than a hip replacement.

There is now overwhelming evidence which clearly shows that ASR was a badly designed resurfacing. The same evidence also demonstrates that the results of the BHR in young patients are very good, the very group who fare poorly with a traditional hip replacement. It would be unfortunate if the bad results from a few ill-designed, poorly implanted devices are allowed to throw this excellent treatment option into disrepute.

The BHR has been implanted in more than 140,000 patients worldwide. It has restored quality of life and returned young patients to their professions. One study found that over 90% of the resurfaced men participated in sporting activities and over 60% participated in impact sports without detriment to their artificial hip. As the inventor of the BHR, Mr McMinn is confident that this technology will stand the test of time as the published evidence has been proving.

It must be remembered however that component malposition is a cause of failure and should be avoided. Choose your device and your surgeon carefully. If you have any further queries, please do not hesitate to contact us: enquiries@mcminncentre.co.uk.

Joseph Daniel FRCS MS(Orth)
Staff Surgeon & Director of Research

Sadwin Raises More Questions – Will They Ever Be Answered? (earlsview.com)
Metal Ion Measurement as a Diagnostic Tool to Identify Problems with Metal-on-Metal Hip Resurfacing (earlsview.com)
Associate Professor Michael J. Neil – Doesn’t Recommend Resurfacing (earlsview.com)
Bruce Greenfield may be the last New Zealander implanted with a faulty hip joint (earlsview.com)
Rottenstein Law Group Curious About Reserves Set Aside by Johnson & Johnson for DePuy Victims (earlsview.com)
Rottenstein Law Group Curious About Reserves Set Aside by Johnson & Johnson for DePuy Victims (prweb.com)
Mr. Michael Solomon, Sydney Australia Surgeon Gives Advice on Hip Replacement (earlsview.com)

Filed under: Australian Joint Registry, Biomet Hip Replacement, Birmingham Hip Resurfacing, Cobalt chrome, DePuy, DePuy ASR Hip, DePuy Hip Litigation, DePuy Hip Recall, DePuy Lawsuit, Hip Replacement, Hip Resurfacing, Johnson & Johnson, Johnson & Johnson lawsuit, Metal on metal hip, Metallosis, Osteoarthritis, Smith & Nephew, Total Hip Replacement Tagged: Birmingham, DePuy, Femur head, Food & Drug Administration, Hip Replacement, hip resurfacing, Johnson & Johnson, metal, One Show, Orthopedic surgery, Patient, surgery, UNited States

Biomet Receives FDA Clearance for Active Articulation(TM) E1(R) Dual Mobility Hip System

earlstevens58 — Sun, 17 Jul 2011 23:23:19 +0000

Image via CrunchBase

My View:

This is looks like a really exciting development – will follow with interest.

Biomet Receives FDA Clearance for Active Articulation(TM) E1(R) Dual Mobility Hip System

WARSAW, Ind.– 4/26/2011 (BUSINESS WIRE)– Biomet, Inc., a global leader in the manufacture of orthopedic and biotechnology products, today announced clearance of its Active Articulation(TM) E1(R) Dual Mobility Hip System, by the United States Food and Drug Administration.

The Active Articulation(TM) Hip System is Biomet’s first hip system in the United States to merge the concept of dual mobility with the benefits of Biomet’s exclusive E1(R) Antioxidant Infused technology and a proven cup design1.

The dual mobility hip concept was developed over 30 years ago2 and has since experienced clinical success.2,3 The concept utilizes a small femoral head that articulates within polyethylene. The large polyethylene bearing, when triggered, acts as a large head bearing that articulates within a metal cup.

“The Active Articulation(TM) Hip System provides an excellent combination of wear resistance and implant stability,” said Jon Serbousek, President of Biomet’s U.S. Orthopedics division. “We believe this new product will provide an important implant solution to orthopedic surgeons performing hip replacement surgery.”

About Biomet Biomet, Inc. and its subsidiaries design manufacture and market products used primarily by musculoskeletal medical specialists in both surgical and non surgical therapy. Biomet’s product portfolio encompasses reconstructive products, including orthopedic joint replacement devices, bone cements and accessories, autologous therapies and dental reconstructive implants; fixation products, including electrical bone growth stimulators, internal and external orthopedic fixation devices, craniomaxillofacial implants and bone substitute materials; spinal products, including spinal stimulation devices, spinal hardware and orthobiologics; and other products, such as arthroscopy products and softgoods and bracing products. Headquartered in Warsaw, Indiana, Biomet and its subsidiaries currently distribute products in approximately 90 countries.

Active Articulation™ Dual Mobility Hip System

Dislocation is second to infection as the main early complication following THA.¹ Dual mobility constructs have demonstrated long-term clinical success in Europe reducing risk of dislocation^1-6 The Active Articulation™ E1® Hip System defines the next generation of dual mobility constructs as it is specifically indicated for patients at risk for dislocation⁸ and the only dual mobility system to utilize Antioxidant Infused Technology.

Dislocation Resistance
Ultra-Low Wear – 95% less wear than traditional THA, even when cup is at 60º inclination⁷
Large Range of Motion – Provides up to 165 degrees⁷
Oxidative Stability – E1® Antioxidant Infused Technology prevents oxidative degradation of polyethylene.⁹
Clinically Proven Cup¹⁰ – The fully-hemispheric M2a-Magnum™ cup contains clinically proven PPS® coating¹¹ and fins to provide fixation and stability

1. Farizon, F. et al. Results with a cementless alumina-coated cup with dual mobility. A twelve-year follow-up study. International Orthopaedics. 22(2):219-24, 1998
2. Langlais, F.L. et al. Dual mobility cemented cups have low dislo¬cation rates in THA revisions. Clinical Orthopaedics and Related Research. 466:389-95, 2008.
3. Philippot, R. et al. The use of a dual-articulation acetabular cup system to prevent dislocation after primary total hip arthroplasty: analysis of 384 cases at a mean follow-up of 15 years. International Orthopaedics. 33:927-32, 2009.
4. Guyen, O. et al. Use of a dual mobility socket to manage total hip arthropalsty instability. Clinical Orthopaedics and Related Research. 467:465-72, 2009.
5. Philippot, R. et al. Prevention of dislocation in total hip revision sur¬gery using a dual mobility design. Orthopaedics and Traumatolology: Surgery and Research. 95:407-13, 2009.
6. Massin, P, Besnier L, Acetabular revision of total hip arthroplasty using a press-fit dual mobility cup. Orthopaedics and Traumatology: Surgery and Research. 96:9-13, 2010.
7. Data on file at Biomet. Bench test results not necessarily indicative of clinical performance.
8. See biomet.com for package insert.
9. FDA Cleared Claim. See biomet.com/e1 for complete claim language.
10. Ongoing, multi-center study demonstrated 99.6% survivorship at 2.5 yeas. Data on file at Biomet.
11. McLaughlin, J.R. and Lee, K.R. Survivorship at 22 to 26 Years Reported with Uncemented Tapered Total Hip Stem. Orthopedics Today. 30(1): 1, 2010.

Technorati Tags: Biomet, Biomet Active Articulation Dual Mobility Hip System

J&J, Hip Makers Asked by FDA for Data on Metal in Patients (businessweek.com)
Studies Ordered for Makers of Artificial Hips (nytimes.com)
Asheboro, North Carolina Residents Banishing Hip Pain with the Help of Top Orthopedic Doctors (bestmedicalpractices.wordpress.com)
A Tale of Two Specialties (jaycaplan.wordpress.com)
DePuy Orthopedics Gets FDA Approval For Ceramic-on-Metal Hip Implant Pinnacle CoMplete System – Is This A Potential Replacement for the Other Ones Out There? (ducknetweb.blogspot.com)
FDA Approves First Ceramic-on-Metal Total Hip Replacement System (nlm.nih.gov)
Biomet Receives FDA Clearance for Active Articulation(TM) E1(R) Dual Mobility Hip System (earlsview.com)

Filed under: Biomet, Biomet Hip Replacement Tagged: Biomet, Business Wire, Clinical Orthopaedics and Related Research, DePuy, Food & Drug Administration, Hip Replacement, Orthopedic surgery, Traumatology, UNited States, Warsaw Indiana

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SUMMARY

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