Hip Resurfacing Devices

I am 6-weeks Post-Op after having my "other" (Left) Hip Resurfaced!

I figured no better way to test my newly resurfaced (15-month old) Right Hip, than to have the Left Hip done! And wow, what a test. 6-weeks of 100% weight on the Right Hip, and not a single twinge, tingle, stab, jolt, throb, pinch, burn, or shooting pain!  I'm convinced the Right Hip has met the test! 

To the date of my recent Left Resurfacing, I was so pleased with the results of my Right Hip procedure, that there was no hesitation or consideration given when I was told "it's time" to have the Left Hip done.

I guess I can say the only draw-back to having my Right Hip done 6 April 2010, was that during that recovery period and "transfer of weight" during my rehab, it rapidly increased the level of deterioration in my other (Left) Hip. Well, no problem with that now!

DePuy has announced that it is voluntarily recalling the ASR™ XL Acetabular Head System and DePuy ASR™ Hip Resurfacing System. DePuy is providing the information below to help visitors with questions and concerns. Visitors are also invited to visit the DePuy website at www.depuy.com.

• DePuy makes patient safety and health a top priority and is continually evaluating data about its products. Most ASR hip replacement surgeries have been successful. However, data recently received by the company shows that more people than expected who received the ASR hip experienced pain and other symptoms that lead to a second hip replacement surgery, called a revision surgery.
• For this reason, DePuy Orthopaedics is recalling its ASR™ XL Acetabular Head System and DePuy ASR™ Hip Resurfacing System. This recall means additional testing and monitoring may be necessary in hip replacement patients.  In some cases, patients may need additional surgery.
• DePuy is working closely with health care professionals worldwide to contact patients with ASR hip implants.  Most people with ASR Hip System implants do not experience problems, but it is important that patients with ASR Hip System implants be evaluated with by a surgeon. Patients with problems reported different symptoms with their ASR hip implant, including pain, swelling, and problems walking. 

• DePuy intends to cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.

Click here for the press release

Click here for the patient information page on our web site

Click here for an image of the ASR Hip System

Medical Release Form:

Patients with an ASR Hip are asked to complete the form and bring it with them to the appointment to give their surgeons permission to share information directly with DePuy.

Click here for the recall notice

This notice was shared with hospitals and surgeons regarding the ASR recall.

New Data Reinforces the Proven Safety and Effectiveness of the BIRMINGHAM HIP Resurfacing System

80-percent of US surgeons choose the BHR hip as it outperforms all other metal-on-metal resurfacing devices

MEMPHIS, Tenn., May 3 /PRNewswire-FirstCall/ -- Recent new data(1) presented at this year's American Academy of Orthopaedic Surgeons (AAOS) annual meeting reinforces the BIRMINGHAM HIP™ Resurfacing (BHR) System as a safe and effective hip resurfacing device. The multi-site study, performed by orthopedic surgeons practicing at nine Canadian academic centers, showed that three years after surgery, 99.91% of their 3,400 hip resurfacing patients experienced no implant failure due to metal wear debris. The BHR Hip was the most used resurfacing device in this study.

This week, the Hospital for Special Surgery (HSS) in New York City will be holding a medical education course titled "Total Hip: Replacement and Resurfacing" on May 7 and 8 for leading hip surgery specialists from across the U.S. Chairing the course will be Edwin Su, MD, of the Hospital for Special Surgery, and the teaching faculty will include pioneering British surgeon Derek McMinn, MD, inventor of the BHR hip.

During a press conference and Q&A webcast on Thursday, May 6, at 3 p.m. US EDT, 8 p.m. GMT, Joseph M. DeVivo, president of Smith & Nephew Orthopaedics (NYSE: SNN, LSE: SN), the maker of the BHR Hip, will be joined by Dr. Su and Mr. McMinn, as well as Scott Marwin, MD, an orthopedic surgeon with New York University's Hospital for Joint Diseases. The panel will review current data confirming the safety and effectiveness of hip resurfacing and the BHR Hip. Smith & Nephew Orthopaedics will host the call, and additional details are at the bottom of this release.

The new study recently presented at the AAOS meeting aligns with previously released BHR Hip data from other prestigious sources and further addresses the metal wear debris concerns raised about metal-on-metal hip implants.  The BHR Hip's track record for longevity remains unchallenged in the literature, as well. These sources include:

• The Journal of Bone and Joint Surgery published in January of this year a study tracking 155 consecutive BHR patients over three years. The data showed no revisions of BHR Hips due to metal wear, but patients who received a competing metal-on-metal resurfacing device were revised within three years of surgery at a rate of 3.4-percent due to adverse tissue reactions.(2)
• The Australian Orthopaedic Association's 2008 National Joint Replacement Registry, a record of nearly every hip implanted in that country over the previous 10 years, tracked 6,773 BHR Hips and found that less than one-third of one-percent may have been revised due to the patient's reaction to the metal component.(3)  
• The Australian Registry hip resurfacing data for 2009, 70-percent of which comes from BHR Hip procedures, indicates that for men under age 65, hip resurfacing performs at the same or a better rate than total hip replacement. This registry also shows that the BHR Hip remains successful in 95-percent of cases eight years after surgery, whereas no other implant performs better than 94.7-percent just five years after surgery.(4)
• Great Britain's Oswestry Outcomes Centre's patient registry,  which tracked 5,000 BHR Hips implanted by 148 different surgeons in 37 countries over 10 years (1998-2008), reports that the BHR Hip remains successful in 95.4-percent of all patient segments 10 years after surgery. This registry also reported that 98.6-percent of patients were "pleased" or "extremely satisfied" with their BHR Hip implants 10 years after their resurfacing procedure.(5)
• Mr. McMinn's clinical data, based on 3,095 hip resurfacing patients implanted between 1997 and 2009, shows that more than 12 years after surgery, the BHR hip remains successful in 99-percent of men aged 60 and over, and 97-percent for men under age 60.

"The BHR Hip's outcomes are remarkable when compared to other resurfacing devices," said Dr. Marwin. "The depth and consistency of the data collected globally shows the BHR Hip is truly different."

"For the right patients in my practice, hip resurfacing has proven to be an excellent choice," said Dr. Su. "They have extremely high levels of satisfaction after returning to their regular lifestyle."

To explain the patient advantages seen consistently in the literature, surgeons indicate the key differences between the BHR Hip and other resurfacing devices are its metal composition, its design geometry and its surgical instrumentation.

The BHR Hip has a unique metallurgy heritage which goes back more than 30 years and includes a first-generation metal-on-metal resurfacing process which contributes to long-term survivorship of BHR Hip recipients.

Additionally, the BHR Hip's design geometry replicates the natural hip's ability to pull the body's own joint fluids into the ball and socket interface, which is believed to be another source of its best-in-class performance.

Of particular importance during hip resurfacing surgery is the correct positioning of the acetabular cup, or hip socket. When this component is not properly aligned, studies show that metal wear can accelerate and resurfacing devices can fail before their time.  Surgeons believe that the instrument used to implant the BHR Hip is simpler and more accurate than other devices' instruments, and may contribute to its success.

"Just like the lubricating barrier in a healthy hip, there is a natural fluid layer between the femoral head and the cup that the two metal surfaces glide across during physical activity," said Mr. McMinn. "If the surgeon malpositions the acetabular cup causing edge loading, the lubrication is lost. It's equivalent to running a car engine without lubrication oil. High wear will occur, resulting in premature failure. Overall, it is a combination of the metal composition, the design and the quality of the surgical technique that makes the BHR Hip the safest resurfacing implant on the market."

"The bottom line is that the BHR Hip is not like other metal-on-metal hip implants," said DeVivo. "Not only does it have the longest track record of any resurfacing device, but the most esteemed medical literature shows it outlasts other implants. It's in a class all its own – it's safe and effective, and is the best choice for active patients."



Footnotes

(1) Beaule PE, Smith FC, Powell JN et al. A Survey on the Incidence of Pseudotumours with MOM Hip Resurfacings in Canadian Academic Centres. Podium presentation # 665. Proceedings of the American Academy of Orthopaedic Surgeons Annual Meeting, New Orleans LA. 2010

(2) Langton DJ, Jameson SS, Joyce TJ, Hallab NJ, Natu S, Nargol AVF.  Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement, A CONSEQUENCE OF EXCESS WEAR. J Bone Joint Surg Br. 2010; 92-B: 38-46

(3) Table HT 46. Australian Orthopaedic Association National Joint Replacement Registry Annual Report. Adelaide: AOA; 2008.

(4) Table HT 46. Australian Orthopaedic Association National Joint Replacement Registry Annual Report. Adelaide: AOA; 2009.

(5) Robinson E, Richardson JB, Khan M. MINIMUM 10 YEAR OUTCOME OF BIRMINGHAM HIP RESURFACING (BHR), A REVIEW OF 518 CASES FROM AN INTERNATIONAL REGISTER. Oswestry outcome centre, Oswestry, UK.

About Us

Smith & Nephew is a global medical technology business, specialising in Orthopaedics, including Reconstruction, Trauma and Clinical Therapies; Endoscopy and Advanced Wound Management.  Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the leading global orthopaedics companies.

Smith & Nephew is dedicated to helping improve people's lives.  The Company prides itself on the strength of its relationships with its surgeons and professional healthcare customers, with whom its name is synonymous with high standards of performance, innovation and trust.  The Company operates in 32 countries around the world.  Annual sales in 2009 were nearly $3.8 billion.

Forward-Looking Statements

This press release contains certain "forward-looking statements" within the meaning of the US Private Securities Litigation Reform Act of 1995.  In particular, statements regarding expected revenue growth and trading margins discussed under "Outlook" are forward-looking statements as are discussions of our product pipeline.  These statements, as well as the phrases "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions, are generally intended to identify forward-looking statements.  Such forward-looking statements involve known and unknown risks, uncertainties and other important factors (including, but not limited to, the outcome of litigation, claims and regulatory approvals) that could cause the actual results, performance or achievements of Smith & Nephew, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements.  Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20F, for a discussion of certain of these factors.

All forward-looking statements in this press release are based on information available to Smith & Nephew as of the date hereof.  All written or oral forward-looking statements attributable to Smith & Nephew or any person acting on behalf of Smith & Nephew are expressly qualified in their entirety by the foregoing.  Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement contained herein to reflect any change in Smith & Nephew's expectation with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.

Advice to patients concerning the ASR

I suggest a few points that, I think, everyone can agree to (for any hip, including an ASR):

1. If you have pain or are in any way concerned - go see your surgeon.

2. There are some screening tests. Based on current experience, if blood (or serum) ion levels of Cr and Co are <5ppb, the likelihood a problem with the implant is low. If the level of either is >10ppb, the likelihood of a problem with the implant is increased. In either event, the next step would be an imaging study (ultrasound or MRI) to look for a fluid collection, or a cystic or solid mass - as evidence of an adverse local tissue response.

3. An aspiration of the joint may be appropriate a) to exclude infection as a cause of the joint dysfunction and b) the characteristics of the fluid may help in the differential diagnosis of a problem related to the metal-metal bearing.

I think that the first point is the most important. If you are concerned, go see your surgeon.

Thomas P. Schmalzried, M.D.

I have to start by saying that I have never had any issues with the ASR devise at all. I was very surprised about 6 months ago when the issue of ASR withdrawal first surfaced. There is no doubt that the safety margin for the ASR is lower than other resurfacing systems like the BHR due to a 'low arc of cover'- described by Dr. Desmet. This is because the rim of the cup has become 'non -articular' to accommodate the cup holder. Hence the failure rate is higher than the BHR.

The cups coming loose is certainly not true as I have implanted ASR cups in the most complex of cases. I am 100% confident that it is a technical issue.

It has proven to be an excellent tool in my hands and in dysplasia patients ( CROWE 3)- the s-rom with a ASR cup combination that is hard to beat.

The ASR reamers are very poor and not matched to the ASR cups. I have routinely used BHR or equivalent reamers for the ASR cups for 3 yrs since the time noticed the mismatch between the reamers and cup size for the ASR

The ASR has been excellent tool to provide an anatomical metal on metal articulation in small patients. I am very confident that it will work well if installed correctly. I will surely miss the ASR cup for small made patients if it is withdrawn completely.

with best regards
vijay bose
chennai

The status of DePuy Orthopaedics’ ASR platform as Feb. 2010

Last fall of 2009, DePuy decided to discontinue ASR® XL Acetabular Head System and DePuy ASR® Hip Resurfacing Platform (not available in the U.S.) worldwide. As a result of declining demand for the ASR platform and other market factors, DePuy is in the process of phasing out this platform to focus on the development of next generation hip replacement and resurfacing technologies that best meet the needs of surgeons and patients.

DePuy wants to assure patients who have been treated with a device from the ASR platform that there will be options available to them in the future should they need a revision:

· If a patient who had received the DePuy ASR® XL Acetabular Head System for total hip replacement requires a revision surgery, the acetabular component could be revised with the Pinnacle Hip Solutions platform, which would be compatible with an existing well-fixed femoral stem.

· As with any hemi-resurfacing prosthesis, including the DePuy ASR® hemi arthroplasty, a patient requiring a revision procedure would generally be treated with a total hip replacement.

· For patients outside the U.S. treated with DePuy ASR® Hip Resurfacing (not commercially available in the U.S.), DePuy intends to maintain an inventory of ASR XL heads outside the U.S. for use on compatible DePuy femoral stems. This will allow surgeons outside the U.S. the option of retaining a well-fixed ASR Cup when appropriate as part of the revision procedure.

Lorie Gawreluk
Vice President, Worldwide Communications
DePuy, Inc.

Smith & Nephew's strong profits beat expectations
February 2010

Smith & Nephew (S&N), the hips-and-knees maker, posted higher profits in the final quarter of last year after the replacement joints market stabilized.

The market suffered during the recession, but started to recover in the second half.

Traditional hip and knee ranges, like its Legion knee, did well, particularly in the US, while products designed for younger, more active patients, such as the bone-sparing Birmingham Hip Resurfacing System, were weak.

Younger patients were more likely to put off surgery than retirees because they did not want to take time off work or balked at the cost.

"Our largest business, orthopaedics, saw a good finish to a tough year," said chief executive David Illingworth. "Market conditions were a little less difficult than in the first half."

He said it’s too early to say when patients who deferred operations might have them done, and S&N is struggling to push through price increases as governments and private clients have tightened their budgets. But Illingworth was hopeful that the $12bn  global market for replacement joints would improve, with consumer confidence returning and unemployment now falling.

S&N expects revenues in orthopaedics to grow at the market rate this year after lagging in 2009.

Profits before tax rose to $175m in the fourth quarter from $162m a year earlier, with revenues 11 per cent higher at $1.07bn, helped by strong sales at the wound management division.

Analysts and investors welcomed the results, and the shares closed up 4.3 per cent at 660p.

Thomas P. Gross, M.D. Midlands Orthpaedics p.a. Current status of uncemented femoral components in hip resurfacing Midlands Orthpaedics p.a.

 January, 2010

Uncemented femoral components for metal on metal total hip resurfacing have shown excellent results during the initial 3 years that I have been using this new technology. The early results that I have achieved in 0ver 800 cases since March 2007 are equivalent to the early results that I achieved with the same brand cemented femoral component.

Uncemented fixation of implants to bone is a proven technology that has generally surpassed the durability of cemented fixation to bone in traditional hip replacement surgery. In the long term (at 10 years) a higher percentage of hip implants using uncemented fixation still remain attached to the bone than cemented implants, especially in younger more active patients.

Fixation of total hip implants to bone can be accomplished by cement or by porous ingrowth technology (uncemented). Cement fixation is immediate. Cement is an acrylic material (methylmethacrylate) that is very brittle and also fairly toxic to bone cells. Cemented implants gradually loosen from the bone over time by reaction to the cement itself and due to gradual fatigue failure of this material. This process is faster in more active patients and faster in implant situations where the cement is stressed by shear forces rather than by compression forces.
 
Uncemented components are initially held to the bone by a very tight press-fit which is achieved by accurately preparing the bone so that the implant can be tightly hammered-on. The implants are so tightly wedged–on that the patient can bear full weight on them immediately. They do require a period of six to twelve months of bone ingrowth before they are considered well fixed. There is usually a small chance of failure of this bone ingrowth process in uncemented implants (<1%). But if ingrowth occurs, it is much more durable than cemented fixation and rarely fails in the long term.
 
Because orthopedic surgeons in America have come to a consensus on the superiority of uncemented fixation in total hips, uncemented fixation has virtually completely replaced cemented fixation in stemmed total hip replacements, despite the fact that these implants are more expensive. 99% of acetabular (socket) components that are used today are of the uncemented type, as are about 90% of femoral stems.
 
In hip resurfacing there is universal agreement that uncemented fixation is superior for the acetabular component. However, until recently, uncemented femoral components have not been available, therefore most hip resurfacing operations in the past have employed cemented fixation of the femoral component.
 
At the time that I began hip resurfacing in 1999, there was not yet general agreement that uncemented fixation was superior to cement in hip replacements. However, the evidence was mounting that uncemented fixation was better. I therefore did not think it was logical to use cemented fixation in hip resurfacing, an operation developed specifically with the more active younger patient in mind. The only companies pursuing hip resurfacing at the time were two small English companies: Corin and Midland Medical Technology (maker of the Birmingham implant). I suspect that they did not have the financial resources to develop a more complicated uncemented femoral component with the precision instrumentation required at that time. I originally proposed an uncemented femoral component to Corin 10 years ago, but they were unable to manufacture it at that time.
 
I therefore worked with Biomet on an uncemented femoral component and the precision instrumentation required for this implant for five years. I first began implanting it in March 2007. The Biomet component has a full coating of Titanium plasma spray under the entire under-surface of the femoral component. Recently we have added an additional layer of hydroxylappatite (HA) to increase the speed and extent of bone ingrowth. This is the best implant available to maximize the chance of bone ingrowth. When I started working with Biomet to develop an uncemented femoral component, Corin also started to work on one. They were able to bring it to market in Europe first; however, their component is only partially porous-coated (less than 50%) with Titanium (but it does have complete hydroxyl appetite coating). I personally do not believe this is good enough for long-term fixation (>10 years), but nobody knows for sure yet. It is not yet available in the US.
 
Theoretically, cement is the weak link when long-term (> 10 years) fixation of the femoral component is contemplated. If uncemented femoral components can be shown to achieve reliably high rates of ingrowth in the short term, they will probably outperform cemented femoral components in the long-term.
 
At this point with nearly 2-year follow-up data on a matched group of patients, I see no difference in results whether cement or uncemented fixation is used. At this point we can be fairly certain that bone ingrowth has occurred in these components. Except for two cases where osteonecrosis occurred in the femoral head at 1 year, we have had no failures of bone ingrowth in 430 patients that have are at least one year postop, and 191 that are at least two years postop.

In summary:

• Uncemented femoral resurfacing components are now available from BIOMET for any patient who desires them.
• No other companies are yet selling these in the US
• Corin has had an uncemented femoral component available in Europe for several years.
• At 2 years of follow-up there is no difference in the failure rate between cemented or uncemented femoral component.
• Uncemented fixation of implants is more durable at 10 years than cement in hip replacement surgery especially in young active patients.
• Most clinical data on hip surface replacement to date is based on an uncemented acetabular component and a cemented femoral component. 
• I now use uncemented components on virtually all hip resurfacing operations, unless the patient specifically requests the cemented femoral device. 

Thomas P. Gross, MD