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Vicky's 2nd Hip
Conserve Plus PDF Print E-mail

Total Resurfacing with the CONSERVE® PLUS Implant
Unlike a total hip replacement, total hip resurfacing allows the patient’s femoral head and neck to be retained and the patient’s femoral canal is not invaded. This procedure helps preserve the patient's bone, as well as, natural motion in the joint.

Wright’s large femoral head components enable the CONSERVE® PLUS Total Resurfacing Implant to offer a hip procedure with excellent stability and range of motion. Many patients with total resurfacing implants enjoy a pain-free life with increased activity levels for many years.

image

Photo: The CONSERVE® PLUS Implant utilizes the same BFH® Technology as the CONSERVE® Total Hip Implant. Thus, the same benefits of large diameter metal-on-metal bearings are maintained. BFH® Technology has produced a superior artificial hip that is more like your normal hip anatomy in size and function

What components make up total resurfacing implants?

image2CONSERVE® PLUS Acetabular Shell and Femoral Head
The CONSERVE® PLUS acetabular component is a super-finished cobalt chrome shell manufactured to the tightest tolerances in the orthopaedic industry. The acetabular component is a "low profile" component, which allows for an additional 10º range of motion compared to "standard profile" shells. This acetabular component mates with a super-finished cobalt chrome CONSERVE® femoral head for excellent metal-on-metal implant longevity. These two components form an extremely stable hip joint because of the size of the femoral heads, which range from 36-56mm in diameter (compared to traditional 28mm heads). The CONSERVE® Family of Implants is designed with BFH® Technology (large femoral heads) which allows for a range of motion up to 172°. This is significantly better than many standard total hip devices which fall into the range of 130° - 135°.*

A key advantage to the increased range of motion offered by the CONSERVE® PLUS resurfacing implant is the reduced chance for dislocation. Remember, hip dislocation is one of the leading causes for failure of a total hip replacement and is a strong advantage of hip resurfacing – almost no dislocations!!
Photo: CONSERVE® PLUS Acetabular Compound X-ray

CONSERVE® PLUS Implant Design
The CONSERVE® PLUS Implant utilizes the same BFH® Technology as the CONSERVE® Total Hip Implant. Thus, the same benefits of large diameter metal-on-metal bearings are maintained. BFH® Technology has produced a superior artificial hip that is more like your normal hip anatomy in size and function. In traditional hip surgery, the diseased hip is replaced with a joint that is much smaller in size which can make the new joint susceptible to dislocation. In contrast, the larger femoral head in the BFH® Technology Hip reduces the chance of post-operative dislocation while increasing the range of motion. In fact, BFH® Technology allows patients to potentially achieve up to a 172° range of motion, compared to 130° - 135° of Wright’s traditional implants.* This extra range of motion can make a big difference for those trying to return to a normal, active life.

Advantages
You do not have to live with hip pain for the rest of your life. Total hip resurfacing is one alternative that can help reduce pain in your joints. Pain relief is the most reliable potential benefit of resurfacing and often the major reason for surgery. For most people, hip resurfacing surgery also offers better movement, strength, and coordination of the torso and leg.

Another benefit is an improvement in the appearance of the limb. Most people who develop a limp in order to cope with the pain of an arthritic condition will no longer limp after surgery. Hip resurfacing surgery may mean the difference between having to use a walker or cane and being able to walk, climb stairs, and maintain a relatively active and independent life.

The CONSERVE® PLUS Total Hip implant is a wonderful option to total hip replacement. The design goals include:

  • Bone stock conservation and preservation
  • Biological bone preservation and normal joint physiology
  • Improved stability
  • Minimal morbidity (disability)
  • Revisability

These advantages have been cited by Dr. Harlan Amstutz in the abstract "Advantages of Metal-on-Metal Hybrid Resurfacing (CONSERVE® PLUS Implant)", which he presented in January 2004. Dr. Amstutz is the recognized world leader in total resurfacing arthroplasty.

Only you and your orthopaedic surgeon can make the decision about how to deal with your hip pain. Total hip resurfacing can improve your quality of life and allow you to return to your daily tasks and low-impact activities with greater comfort. Call your orthopaedic surgeon today to see if you are a candidate for the CONSERVE® PLUS implant.

Study Results
Following the reintroduction of metal-on-metal articulating surfaces for total hip arthroplasty in Europe in 1988, Wright Medical developed a surface arthroplasty prosthetic system using a metal-on-metal articulation. The present study describes the clinical and radiographic results of the first 400 hips treated with metal-on-metal hybrid surface arthroplasties at an average follow-up of three and a half years.

The studies highlighted in this section validate Wright's commitment to our customers and the patients they serve. Wright is committed to the continual improvement in the wear and functional performance of metal-on-metal hip bearings through design, material and production process optimization.

Metal-on-Metal Hybrid Surface Arthroplasty: Two to Six-Year Follow-up Study (MH015-104)
By Harlan C. Amstutz, MD, Paul E. Beaule, MD, FRCSC, Frederick J. Dorey, PhD, Michel J. Le Duff, MA, Pat A. Campbell, PhD, and Thomas A. Gruen, MS

CONSERVE® PLUS Metal-on-Metal Frequently Asked Questions

1.) How long has metal-on-metal articulation been in use?
George McKee of Norwich, England, was the first to use metal-on-metal articulation with modified Thompson stems and a one-piece cobalt chrome socket combination in THR in 1953. The design was primitive, but many lasted for more than 14 years. In 1986, August et al. reviewed 657 total hip arthroplasties performed by McKee and Farrar.  The combined survival rate of the hip and stem at fourteen years was 84.3%.  Loosening was cited as the main cause of failure, and bone cement was cited as the main culprit.  The authors never implicated metal-on-metal articulation as a reason for complications in their paper.5  Although metal wear was detected in devices that were revised, McKee did not observe any undesirable effects of that debris on the soft tissues or the bone.6  The early history of metal-on-metal devices, including Dr. Amstutz ' experience with the McKee device in New York, has been previously published.7-9

2.) What is the optimum material for metal-on-metal articulation?
Metal-on-metal articulation is typically associated with the cobalt chromium molybdenum alloy.  These alloys are divided into two categories: high carbon, where the carbon content is above 0.20%; and low carbon, where the carbon content is less than 0.05%. Several studies comparing both groups have been conducted.  Earlier studies presented inconclusive results.10  By comparison, later studies isolated the contribution of factors such as surface finish, clearance, sphericity and carbon content. There is now general consensus in the industry that the high carbon alloy has much better wear resistance than the low carbon type.11

In addition, there are two types of processes used in manufacturing the cobalt chrome molybdenum components.  One method is casting the components (used by Wright for the CONSERVE® PLUS and CONSERVE® Total implants). The other is forging the material. Although the chemical composition can be exactly the same between the two materials, there is a structural difference. The grain size of the forged alloy is typically less than 10 microns, whereas the grain size for the cast material ranges from 30 to 1000 microns.  There is also a marked difference in the appearance of the carbides, in that the carbide regions tend to be smaller in the forged material.  Metal liners and femoral heads have been produced at Wright with both types of material. A limited number of couples were tested in a hip wear simulator. The test showed less wear with cast high carbon alloy than the forged alloy.  Due to the limited number of samples, the difference had low statistical reliability.11 This study was the basis for Wright’s decision to use cast cobalt chrome alloy as the material of choice for their metal-on-metal components.

3.) Does the clearance between articulating components play a role in wear debris generation?
Absolutely! This is probably the most influential factor in wear behavior.  The proper clearance is essential for entrapping the synovial fluid between the articulating surfaces.  This fluid is largely responsible for separating the surfaces while the joint is in motion, thereby reducing wear. If the gap between components is too small or too large, there is a sharp increase in wear rates.12  A study conducted by Isaac, Dowson and others (DePuy International, Leeds, UK) compared wrought and as-cast components with various clearances between those two groups. The results of the hip simulator study strongly indicated that clearance plays a major role in wear rates and that "wear appears to be relatively insensitive to changes in materials that have similar chemical compositions but different microstructures."20

4.) Does the CONSERVE® PLUS acetabular shell with the big femoral head use the same clearance for all sizes?
No.  The clearance between components is size-dependent. The larger the diameter, the larger the gap between the components. The range for the entire family of sizes is from 90 to 200 microns of diametral clearance, each bearing size having an optimized gap for maximum fluid film thickness.

5.) I've heard a lot about heat-treated cobalt chrome components versus "as cast" components. What are they talking about and is there a difference?
Cobalt Chrome Molybdenum components that are cast usually go through the hot isostatic pressing (HIP) and solution annealing processes to remove microporosities often found in castings and to improve the ductility and homogeneity of the material.  The microstructure of this type of heat-treated material looks different from that of the original casting. It is important to note that even though heat-treated material looks different, it doesn’t affect wear. Two global metal-on-metal resurfacing manufacturers use the heat-treated process for the castings (Corin, LTD. and Wright).  Midland Medical, the producer of the Birmingham Hip Resurfacing (BHR) implant, leaves the castings untreated.  The BHR product champion, Derek McMinn, MD, claims that heat treatment can lead to carbide depletion, which can adversely affect wear rates.  One "pin on disk" type test suggests that "as cast" material wears slightly less than "HIP" cast material; however, the data shows so much scatter that the results are inconclusive.15 In addition, the linear tracking motion of the type of "pin-on-disk" used in that study is very different from the actual hip motion.  A linear tracking pin-on-disk test is conducted by sliding the cylinder on the flat surface back and forth along one axis.  The actual movement of the femoral head inside the socket produces crossing path motion. Studies in hip simulators are more relevant since they more closely resemble the actual hip function by reproducing this crossing path motion. It has been shown that a linear tracking pin-on-disk test under-estimates UHMWPE wear rates by 10 to 100 times, and overestimates metal-on-metal wear rates as compared to hip simulators and retrieval studies.17  Midland Medical has not published any data from a hip simulator to support their claim. Also, zero clinical studies have been conducted which suggest BHR components create less wear than heat treated components.

Bowsher et al. conducted a hip simulator wear study in which 40mm diameter metal-on-metal bearings, either "as cast" or heat treated, were compared side-by-side.13  Wear rates were compared for the running-in state (first 1 million cycles), steady state, and also fast jogging.  In all three conditions, there was no difference between wear rates of the two forms of the alloy.  The authors concluded that HIPing and solution annealing do not adversely affect the wear rates of large diameter metal-on-metal articulations.  Furthermore, one additional study was presented at the recent June 2003 Conference on Metal-on-Metal Devices in Montreal that corroborate the Bowsher study.20

6.) What is the "steady-state" wear?
Typically, metal-on-metal couples in the hip simulators go through the "run-in" or "wear-in" period where the weight loss due to wear increases linearly. At some point, usually between 500,000 and 1 million cycles, the wear increase drops dramatically or stops altogether.  It is then said that the metal-on-metal couple reached the "steady-state" of wear.

7.) Does the surface finish affect wear rates?
Surface finish has a definite effect on wear rates. The rougher the surface finish, the higher the peaks of material that eventually will be removed. Typical surface finish for the CONSERVE® resurfacing components is 0.008 microns (micrometers). This is an order-of-magnitude smoother than the finish on typical metal femoral heads articulating with polyethylene inserts used for THR.

8.) Do larger heads wear less than smaller heads?
Theoretically, if the metal couple is dry, larger heads should wear more than smaller heads due to their longer sliding distance per step. However, in the presence of the fluid the opposite is true: larger diameter heads should wear less because of their greater sliding velocity.  Calculations show that larger diameter wear couples can form a thicker synovial fluid film between components.12

Hmin = 1.64D(_Ú/ED)0.65(W/ED2)-0.21
Hmin
is the minimum film thickness
D is the head diameter
Ú is the entraining velocity

According to the formula above, the larger the articulating diameter, the larger the Hmin value.  A thicker fluid film means less contact between hard surfaces during motion and, presumably, less wear.  Does this theory prove itself?  The study cited above compared 22mm, 26mm and 35mm diameter metal-on-metal articulations and found no difference between the three. Isaac compared 16mm, 22mm, 28mm, 36mm and 54.5mm diameter couples and, for diameters 28mm and larger, it was determined that wear decreases with increasing head diameter.20

In the study of the 54mm articulating couple conducted at Wright, the wear rates were found to be very similar to the wear rates for the 44mm CONSERVE® PLUS articulating couple performed at another institution.  These numbers are in agreement with other experimental data obtained with hip simulators.

9.) What do they mean when they say that cobalt chrome is "self-healing"?
A cobalt chrome articulation has the ability to polish out the scratches from abrasive damage such as third-body wear.  In retrieval studies, the deep scratches have often been partially or entirely polished out of the main contact zones.

10.) What is the average particle size for metal wear debris?
In one study, the cobalt chrome particles from a McKee-Farrar metal-on-metal articulation were in the range of 6 to 744 nm (nanometers), with an average size of 42 nm.16  By comparison, polyethylene particles range from 0.05 to 5 micrometers (50 to 5000 nm).

11.) Can a metal-on-metal articulation prevent osteolysis?
Since a metal-on-metal articulation does not eliminate wear entirely, there is always the potential for an osteolytic reaction.  There are reports of isolated cases of osteolysis with metal-on-metal joints.17However, these are mostly limited to the first-generation metal-on-metal components.  Those were implanted with acrylic cement, which can fragment and generate third-body abrasive particles.  It is believed that the metal debris is too small, in comparison to the polyethylene particles, to initiate an osteolytic reaction.  A study of several metal-on-metal components (Metasul ™ total hip replacements and McMinn surface replacements) investigated the bone and tissue reactions to the metal debris.18 It was noted that metallosis (a grey-black appearance of the soft tissue) was present with the surface replacements and the total hip replacements.  Macrophages filled with metallic particles were found in all tissues, but in larger amounts in those with metallosis.  Giant cells and small areas of histiocytic granulomas were also present. The authors noted that there were fewer macrophages and giant cells than typically seen in tissues around metal-polyethylene joints, and although an inflammatory response to the metal particles was present, this was not as severe as the response to the cement particles.  The authors concluded that the long-term response to these very small CoCr particles should be monitored.  There has been no observed occurrence of metallosis in connection with CONSERVE® PLUS or CONSERVE® Total implants.

CONCLUSIONS:
Many factors affect metal-on-metal wear behavior.  Some of them are more significant than others.  Surface finish, appropriate radial clearance and high carbon content have been shown to play the greatest role in reducing wear rates.

The microstructure of the alloy does not play a key role in wear behavior. "As cast" and heat treated alloys were directly compared in hip simulators by the scientists from Corin, DePuy, Centerpulse, and in some independent laboratories, all showing similar wear rates for both types of alloy.  Proponents of "no heat treatment" regimes have not provided us with laboratory or clinical data to date. McMinn’s claim of better metallurgy with the "as cast" components is based primarily on "pin-on-disk" type testing.  The "pin-on-plate" or "pin-on-disk" type experiment can compare the wear of different materials as a flat surface, but the mechanism of these tests has nothing in common with the motion of the hip joint.

Hip simulators offer the most reliable way to assess wear in the laboratory, but keep in mind that the outcome greatly depends on the method, testing equipment, and measuring equipment.  Since we are dealing with tiny amounts of debris, test results may vary greatly from one hip simulator study to another.  Take that into account when comparing data between two tests conducted by different people and with different equipment.

Finally, the best proof of a good design is in the clinical outcome.  The CONSERVE® PLUS metal-on-metal articulation has a good clinical history with over 6 years and over 1300 patients.  The paper presenting the clinical results of the first 400 CONSERVE® PLUS hip resurfacing cases performed at the JRI has been accepted for publication by the Journal of Bone and Joint Surgery.

 
The Birmingham Hip Resurfacing (BHR) PDF Print E-mail

BHRThe Birmingham Hip Resurfacing (BHR) prosthesis is a metal-on-metal hip resurfacing prosthesis. The device consists of a stemmed femoral head resurfacing component designed for cemented fixation, and a hemispherical acetabular cup designed for cementless, press-fit, fixation. Both components are manufactured from high carbon, as-cast, cobalt chrome (CoCr) alloy (ASTM F75 and ISO 5832-4). The acetabular cups are configured in standard, dysplasia, and bridging designs. All acetabular cups have a single layer of integrally-cast CoCr-alloy (ASTM F75 and ISO 5832-4) beads on the outer surface that are coated with hydroxyapatite (HA) (ASTM F1185). Instrumentation sets are provided as standard; several additional instruments are available as options.

Resurfacing Femoral Head
The resurfacing femoral head is supplied in a range of eleven sizes. The femoral head central stem is parametric and varies proportionally with the external diameter. There are 6 equally spaced internal recesses intended to provide anti-rotational locking for the cement mantle.

Acetabular Cups
The standard acetabular component is supplied in a range of twenty two sizes (two for each femoral head size to address the condition of occasional head cup mismatch). For those patients with a deficiency in the superolateral aspect of the acetabulum, the dysplasia cup is available. The dysplasia cup is designed with two superolateral screw holes that accommodate CoCr-alloy dysplasia cup screws. There is a range of eleven sizes for the dysplasia cup. A bridging cup is designed with a thicker wall section than the dysplasia cup to allow for mismatch between femoral head size and surgically prepared acetabulum. The bridging cup is also designed with two superolateral screw holes that accommodate the CoCr-alloy dysplasia cup screws. The bridging cup is available in ten sizes.

Dysplasia Cup Screws
The dysplasia cup screws are threaded through a threaded lug on the superolateral aspect of either the dysplasia or bridging cup and lock in situ. The screws also lock into the posterior cortical bone of the ilium. Screws are available in sizes ranging from 24mm to 88mm, in 2mm increments.
table

Sizing and System Compatibility
Each femoral head resurfacing component is compatible with two standard acetabular cup sizes and one dysplasia or bridging cup size (Table 1).

Table 1: BHR Head and Cup Sizing and System Compatibility

BHR Femoral Head
Resurfacing Component
(identified by head outer
diameter)
Mating BHR
Standard Cup Sizes
(2 cups available per
head component size)
Mating BHR
Dysplasia Cup
Sizes
Mating BHR
Bridging Cup
Sizes
38mm 44mm or 46mm 46mm 50mm
40mm 46mm or 48mm 48mm 52mm
42mm 48mm or 50mm 50mm 54mm
44mm 50mm or 52 mm 52mm 56mm
46mm 52mm or 54mm 54mm 58mm
48mm 54mm or 56mm 56mm 60mm
50mm 56mm or 58mm 58mm 62mm
52mm 58mm or 60mm 60mm 64mm
54mm 60mm or 62mm 62mm 66mm
56mm 62mm or 64mm 64mm 68mm
58mm 64mm or 66mm 66mm -



Content from Dr. John Rogerson’s website

September 23, 2010

On any changes of the BHR device since the first one (as it stands today) was implanted in July 1997, here is a quote from Derek McMinn, the  inventor of the BHR

"Dear Vicky,

The only change in the BHR over the years is that when we started back in '97 there were 4mm increment sizes on the femoral component. Eventually 2mm increments were introduced on the femoral side. Some surgeons still don't use the 2mm increments-- I moved to them as soon as they were available, Ronan & some other surgeons still use 4mm femoral component increments I gather. Don't think it's a big deal whichever option the surgeon uses.

I haven't got a femoral loosening since I moved from cementless resurfacing femoral components 18 years ago-- cementless can work well, but hard to beat ZERO loosening with the BHR cemented femoral component!

Best regards
Derek" 

just a note, the first prototype was implanted over 20 years ago, that is the first design of the BHR that was slightly different has been around 20 years this year.

 

Update May 2011

McMinn DJW, Daniel J, Ziaee H, Pradhan C. Indications and results of hip resurfacing. Int Orthop. 2011;35(2):231-237

"The best indication for hip resurfacing is a young active patient with severe hip arthritis, good hip morphology and reasonable bone quality. With revision of either component for any reason as the endpoint, there were 68 revisions in our series of 3,095 consecutive Birmingham Hip Resurfacings (BHR) (1997-2009), including all diagnoses in all ages. This equates to a revision rate of 2.2% and survivorships of 99, 97 and 96% at five, ten and 13 years, respectively. In patients under 55 years with osteoarthritis, the survivorship is 99 and 98% at ten and 13 years. These results provide medium-term evidence that BHR when performed well in properly selected patients offers excellent outcomes and implant survivorship. Small changes to implant materials and design can affect joint function and survivorship significantly as seen from the withdrawal of certain resurfacing devices recently from clinical use. The clinical history of one device cannot be extrapolated to other devices."
 

 
Stryker Cormet Corin PDF Print E-mail

In the late 1980’s, another British Surgeon suggested combining two earlier concepts of metal-on-metal bearings and Hip Resurfacing, to create metal-on-metal Resurfacing of the hip joint. Corin pioneered the development of this technology and introduced the first metal-on-metal Resurfacing Hip system in 1991. This has a number of major differences from a conventional THR:

  • In Hip Resurfacing, both components are made from metal. By eliminating the plastic socket in a conventional THR, and making both parts of the bearing surface of metal, the new Resurfacing Hip system is intended to last much longer, and therefore be more suitable for higher demand patients.
  • The bearing is also a much larger diameter than is used in a conventional Total Hip Replacement – it is almost identical to the size of the head of the natural femur. This is much less likely to dislocate than the smaller diameter bearing of a THR, and this means that patients can return to higher levels of activity without worrying about dislocating their implant.
  • Finally, the procedure is very bone conserving, since the head of the femur is simply reshaped and resurfaced, rather then being removed. Should the device need replacing at some time in the future, this may provide better options for the Surgeon at that time, as a conventional THR may then be used.

 

 

Cormet

Resurfacing of the Hip is a relatively new procedure and does not have the long-term clinical follow-up results that are available for some other types of conventional THR. Not all Surgeons are experienced in Resurfacing of the Hip.  The procedure is intended for use in a specific group of younger (usually patients under the age of 65), high demand patients. Your Orthopaedic Surgeon is the only person who can advise you whether you are suitable for such an operation.

 

 

 

 

 

In recent years the use of “minimally invasive” techniques has become more widespread and surgeons are using smaller incisions, with less disruption to the soft tissues around the hip. The instruments used in the Cormet Hip Resurfacing system are designed to allow the surgeon to implant the resurfacing using these minimally invasive techniques.

If you are suitable, it is likely that you will be able to return to relatively normal levels of activity, and many Resurfacing patients have been able to partake in modest recreational sporting activities with their new hip. The Resurfacing device should last for many years, and should not require revising as early as a conventional THR, but as it is still a relatively new device it will take some years before the long-term results can be confirmed.

 

 

 
Depuy/ASR PDF Print E-mail

LATEST NEWS ON RECALL OF THE ASR DEVICE 

June 2011

BMJ Video interview with Tony Nargol, Tom Joyce and David Langton on results of the ASR that their Centre experienced

BMJ Interview Click here

also see this section on info from Mr. Tony Nargol, M.D, just click here .

And to download Tony Nargols British Orthopaedic Presentation 2011  October (with his permission) click here

BOA Accelerated Failure of the ASR XL at North.pptx


May 2011

RESPONSE TO ABC's 4 Corners Program in the UK Click here

Or Download PDF Here


For info from some top hip resurfacing surgeons on the ASR device and recall

Click here


For more Articles related to this

Blood metal ion concentrations after hip resurfacing arthroplasty

And click here for these other realted articles from JBJS

Accelerating failure rate of the ASR total hip replacement

Adverse reaction to metal debris following hip resurfacing: THE INFLUENCE OF COMPONENT TYPE, ORIENTATION AND VOLUMETRIC WEAR

Early failure of the Ultima metal-on-metal total hip replacement in the presence of normal plain radiographs

Optimal acetabular orientation for hip resurfacing

Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: A CONSEQUENCE OF EXCESS WEAR

 

FROM DEPUY

August 28, 2010

(To read responses from some of the top Hip Surgeons that used the ASR click here )

DePuy ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System Recalled 

DePuy has provided me with this information to share on my web site, for more detailed information go to their website, www.depuy.com

 

Recall Background

  • 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 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.

Additional resources concerning the DePuy ASR can also be found at DrugWatch.com, which offers extensive information regarding medical devices used by both medical professionals and the public. To visit their site click on this link which will take you directly to info on the DePuy Hip Recall for more information.

ASRTM 

Updated February 24, 2010

**Last fall (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, they are 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.**

From Depuy:

"We want to assure patientswho 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 AcetabularHead 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.

·    


 

Advancing a clinically proven procedure(1, 2)
Introducing high performance bearing technology

  • Bone preserving implant profile
  • Optimised bearing clearance and deflection for fluid film lubrication and lower wear
  • Precise tissue sparing surgery
  • Cementing technique, a critical success factor

    deviceThe concept of surface replacement in hip surgery goes back over 70 years. Through three generations of design and materials technology, surgeons and manufacturers have attempted to develop systems that combined conservative bone preparation with acceptable long-term survivorship. Until recently, the results have not matched those for total hip replacement (THR). However, the ground breaking work done by Mcminn, Treacy, Lin and Pynsent has confirmed this approach as a reliable alternative to THR.(1, 2) The DEPUY ASR System advances current design, bearing technology and instrumentation to produce a more reliable and precise approach for early surgical intervention. It also introduces sophisticated instruments and a surgical technique that minimises trauma to the patient.




Depuy Orthopedics, Inc., a Johnson & Johnson company,  Acquires Finsbury Orthopaedics LimitedWARSAW, IN – Dec. 11, 2009 – DePuyOrthopaedics, Inc. has announcedthe acquisition of Finsbury Orthopaedics Limited, a privately held UK-based manufacturer and global distributor of orthopaedic implants.

ADEPT®

Finsbury Orthopaedics has set the standards in metal-on-metal design and manufacturing technology since the early 1990s. The ADEPT® Hip System is the accumulation of our experience and includes both resurfacing and total hip options.

AdeptUniqueflexibility of sizing is provided with 2mm incrementson the head which allows for two cup sizes for every head and two head sizes for every cup. Not only is this feature bone conserving, it also assists with optimising the range of motion.

The critical features of the ADEPT® system and technical rationale are based entirely on clinical history rather than short-term mechanical studies. The ADEPT®metal-on-metal resurfacing system follows well-established clinical history and has evolved from the Ring hip and Birmingham Hip Replacement.

The parallel stem inside the resurfacing head prevents cement migration into the femoral neck during impaction. The tapered section outside the head avoids intimate bone contact within the neck which reduces the riskof load transfer and stress shielding.

ADEPT® Cup
The cup has an as-cast beaded structure for bone ingrowth which is encouraged by a coating of hydroxyapatite.

The beaded surface extends from the edge of the cup right over the pole providing the maximum opportunity for bone ingrowth and secure fixation.

The range of motion before neck infringement has been optimised and found to be superior to other competitive systems.
Adept1
ADEPT® metal-on-metal bearing
The articular surface is a precision bearing, controlled using proprietary techniques developed specifically for metal-on-metal arthroplasty. The all-important block carbide structure present at the bearing surface of the clinically proven Ring prosthesis has been accurately reduced.

Simulator testing on competitive devices has concluded that the life of ametal-on-metal implant is bi-phasic (bedding-in followed by steady-state wear). Retrieval analyses however show that metal-on-metal implants do fail and therefore there is a third phase to the life of theimplant. All three stages of life are predictable and a function of theinitial design.

Simulator studies stop during the steady-state wear phase and often onlyextend to five million cycles which, depending on the patient's activity levels, only represents a lifespan of one to five years. The ADEPT® technical rationale is entirely based on clinical history dating back over 25 years.

 


Read more...
 
Biomet PDF Print E-mail
For info on the Biomet 'Other' System click here
 
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