Total Joint Replacement News
DOJ and Implant Makers Settle Over Consulting FeesSeptember 27, 2007The United States Department of Justice (DOJ) has reached an agreement with implant makers over payments made to orthopedic surgeons as consulting fees. The DOJ has contended that such fees are used to obtain exclusive access to certain surgeons, and unless substantial consulting work is demonstrated such fees could be considered illegal kickbacks.
Under the agreement four companies will pay substantial fines and agree to be monitored for 18 months to ensure full compliance with consulting rules. Biomet will pay $26.9 million; DePuy, $84.7 million; Smith & Nephew, $28.9 million; and Zimmer will pay $169.5 million. A fifth company, Stryker Corp., will not pay a fine, but will likewise be subject to monitoring. Stryker was not fined because they began cooperating with the DOJ before the others.
FDA Approves Corin Cormet Hip Resurfacing for Marketing in USJuly 3, 2007The FDA has approved the Corin Cormet Hip Resurfacing device for marketing in the United States. Stryker Corp announced that it expects to be prepared to distribute the Cormet device beginning in the third quarter. Stryker has an exclusive agreement with Corin to distribute the Corin Cormet in the United States. Strker Press Release: Cormet Approval FDA Approves Birmingham Hip Resurfacing for Marketing in USMay 9, 2006The FDA issued an approval letter allowing Smith and Nephew to begin marketing of the Birmingham Hip Resurfacing brand of metal-on-metal hip resurfacing. Smith and Nephew had recently purchased Midland Medical Technologies, the developers of the Birmingham Hip. Subsequently they filed for approval to market in the US based on their experience and results in England. In September of 2005 they received a recommendation for conditional approval from the FDA's independent orthopaedic advisory panel.
This FDA announcement completes that conditional approval. As part of the company's approval they are required to do special monitoring on a select group of patients in place of a pre-approval clinical trial. Some other monitoring conditions were also attached. DePuy Announces Roll-out of ASR XL Metal-on-Metal HipMarch 21, 2006DePuy Orthopedics, a unit of Johnson and Johnson, announced the roll-out of their ASR XL brand metal-on-metal total hip replacement device at the 2006 Annual Meeting of the American Association of Orthopedic Surgeons. The company reports that the ASR XL is offered in sizes ranging from 39-55 mm in diameter. These allow for a more natural sized joint than the 28-mm diameter joints commonly used. DePuy joins Wright Medical and Biomet as companies offering natural sized metal-on-metal articulated hip replacement devices in the United States. Depuy Press Release 2006 Charnley Award Goes to Hip Resurfacing Research TeamFebruary 1, 2006A research team from the Los Angeles Orthopaedic Hospital and J. Vernon Luck, M.D. Research Center will be awarded the 2006 Charnley Award for their research in hip resurfacing at the annual meeting of the Hip Society in March. The multi-center research team, led by Dr. Harlan Amstutz, M.D., includes first-author Patricia Campbell, Ph.D., and co-authors Paul Beaulé, M.D., Edward Ebramzadeh, Ph.D., Michel LeDuff, M.S., Koen De Smet, M.D. and Zhen Lu, Ph.D. The team's research focused on the analysis of retrieved metal-on-metal hip resurfacing prostheses. The award is named after Sir John Charnley, the father of modern total hip replacement, and is recognized as one of the most prestigious distinctions in the field of orthopaedic research. This award marks the sixth Charnley Award in Dr. Amstutz's career. 2006 Charnley Award Press Release Biomet Receives FDA Approval for its Ceramic-on-Ceramic HipDecember 21, 2005Biomet announced it has received FDA approval for marketing of its ceramic-on-ceramic hip in the United States. Biomet will begin immediate sales of its C2a-Taper acetabular system using ceramic-on-ceramic articulation and Biomet's Porous Plasma Spray technology. Biomet Press Release Zimmer Receives Approvable Letter for Ceramic-on-Ceramic HipDecember 14, 2005Zimmer announced it has received a letter from the US FDA stating that its ceramic-on-ceramic hip, part of its Trilogy line, was approvable for marketing in the United States, subject to inspection of its manufacturing plant. The system will be marketed as the Trilogy AB femoral head and acetabular cup. Zimmer Press Release FDA Panel Recommends Conditional Approval for Hip Resurfacing DeviceSeptember 8, 2005The Orthopaedic Devices panel of the FDA Center for Devices and Radiological Health recommended that the Smith and Nephew Birmingham Hip Resurfacing Device (BHR) be approved for marketing in the United States conditional on the company conducting a 10-year follow-up study of patients receiving the device. The BHR is a metal-on-metal articulation device which replaces the surface of the femoral head with a metal cap.
It differs from total hip replacement in that the femoral head is largely preserved and there is not a stem inserted into the femoral canal. FDA to Review Birmingham Hip ResurfacingAugust 18, 2005The Orthopaedic Devices panel of the FDA Center for Devices and Radiological Health will review the Birmingham Hip Resurfacing (BHR) device on September 8th, 2005 in Gaithersburg, Maryland. The BHR is a metal-on-metal articulation device which replaces the surface of the femoral head with a metal cap. It differs from total hip replacement in that the femoral head is largely preserved and there is not a stem inserted into the femoral canal. Smith and Nephew completed their acquisition of Midland Medical Technologies, the developers of the BHR, in March, 2004. FDA Orthopaedic Panel Meeting Announcement Smith & Nephew Press Release Canadian Report: Obese More Likely to Need Joint ReplacementAugust 17, 2005The Canadian Institute for Health Information (CIHI) has released a report showing that recepients of joint replacements in 2003-2004 had a greater rate of obesity than the general population. The CIHI cited the higher incidence of osteorthritis due to the strain of carrying additional weight as the most likely reason for the statistical result. Additionally the group found that obese patients have greater difficulty in recovering from hip and knee replacement procedures. Additional statistics from the Canadian Joint Replacement Registry are presented in their report, linked below. Full Text of Report from Canadian Institute for Health Information Stryker Signs Marketing Agreement with CorinAugust 11, 2005The Stryker Corporation has signed an agreement with the Corin Group to distribute the Corin Cormet hip resurfacing device and the Corin Optimom large-head metal-on-metal hip replacement system in the United States. The agreement is for the next ten years and is dependent on achieving FDA approval for marketing the devices in the USA. Stryker Corporation Press Release Corin Group Press Release FDA: A Hearing or Headfake for Hip Resurfacing?July 23, 2005The FDA Center for Devices and Radiological Health has added a proposed date to its calendar for the Orthopedic Panel on September 8 and 9, 2005. An agenda for the added meeting has not yet been announced. One device that has been in the queue for quite some time is the Conserve Plus hip resurfacing device from Wright Medical Technology. The clinical results for the Conserve Plus were submitted to the FDA in December 2003 and accepted in March 2004, but have not been reviewed in a public hearing to date. U.S. Dept of Justice Subpoenas Hip and Knee ManufacturersMarch 31, 2005As part of an investigation into the marketing practices of hip and knee prosthesis manufacturers, the U.S. Department of Justice has served subpoenas on several manufacturers, requesting records of research contracts and consulting agreements with surgeons written between January, 2002 and the present. There is concern that research contracts may have been used as a means to pay kickbacks to surgeons in return for using a specific manufacturer's products. Subpoenas were served to Stryker Corp., Biomet Inc., Smith and Nephew, and Depuy, a division of Johnson and Johnson. FDA Approves Second Generation Crosslinked PolyethyleneMarch 9, 2005Biomet Inc. has announced that it has received marketing approval from the U.S. FDA for its second generation highly cross-linked polyethylene, sold under the brand name ArComXL. The company reports the ArComXL has demonstrated a 47-64% reduction in wear compared to its ArCom polyethylene. Polyethylene is used in some hip and knee prostheses as a bearing surface. Biomet Press Release FDA Approves Smith & Nephew Ceramic HipDecember 21, 2004The FDA has approved the Smith and Nephew Reflection Ceramic-on-ceramic hip replacement device for marketing in the United States. The Reflection ceramic adds to the Reflection line of bearing surface options. The ceramic components will be manufactured for Smith and Nephew by Ceramtec of Germany. Previously the FDA approved ceramic-on-ceramic hips by Wright Medical, Stryker/Osteonics and Biomet. Ceramic-on-Ceramic Hips Explained Smith and Nephew Press Release Smith and Nephew Home Page FDA Rejects New Oral Anti-clotting DrugSeptember 10, 2004On September 10, 2004 an FDA panel issued a negative opinion on a new oral anti-clotting drug being developed by Astra-Zeneca citing concerns that the risk of liver damage outweighed the benefits compared to current oral anti-coagulents such as Warfarin. The new drug, Exanta was designed to be used to prevent deep vein thrombosis (DVT) after hip replacement surgery, and would be a replacement for the current anti-DVT treatments. Although Waferin is inexpensive, it requires careful monitoring and the anti-clotting response is sensitive to patient diet. Exanta would not require the expense and inconvience of frequent blood tests, and the product works by means of a different pathway which is not sensitive to patient diet. AstraZeneca Home Page Decision Information from FDA Committee.com Hip Replacement Documentary Premiers in AugustJuly 16, 2004Emmy Award winning fim producer Peter Rosen has produced a television documentary, "Total Joint Replacement: A Patients Perspective" which will premier in early August. The show follows four joint replacement patients and offers a view of orthopedic surgery from the patients' point of view. The program will premier on WNYE-TV in New York City on Aug 1 at 2 pm and will be aired again on Aug 6 at 8 pm. Other broadcasts on public broadcast stations across the country are anticipated. Funding came from the American Association of Hip and Knee Surgeons (AAHKS), the Orthopaedic Research Education Fund, and several orthopedic manufacturers. AAHKS Documentary Web Page Biomet Signs to Partner on Diamond-Coated Hip ReplacementsJuly 13, 2004Biomet has signed an agreement with Diamicron, Inc of Provo, Utah to develop and distribute a diamond coated hip implant system. With the agreement, Biomet joins Exactech as partners with Diamicron. The Diamicron polycrystalline diamond composite coated hip offers extremely high wear resistance. The hips are still in the development stage and no clinic trials have begun. Biomet Press Release Biomet Home Page I-Flow ON-Q PainBuster Approved for Post-Surgical PainMay 25, 2004The FDA has approved the I-Flow ON-Q PainBuster to reduce post-surgical pain. The ON-Q system supplies local anesthetic near the surgical site via a patented catheter and pump. The use of the local anesthetic can reduce, or even eliminate, the use of narcotic pain relievers. Avoiding narcotic pain relievers is beneficial in that it removes the risk of narcotic side effects, such as nausia, drowsiness and constipation, and thereby speed patient recovery and increase patient comfort. Press Release Information for Patients I-Flow Corporation Website DePuy Enters North American Hip Resurfacing Market with ASRMarch 23, 2004DePuy (a division of Johnson and Johnson) has entered the North American metal-on-metal hip resurfacing market. Dr. John Antoniou of Sir Mortimer B. Davis - Jewish General Hospital of Montreal recently performed four hip resurfacings using the DePuy Articular Surface Replacement (ASR) device. Hip resurfacing is designed to preserve the patient's bone while retaining the natural size of the hip joint for greater stability and reduced risk of dislocation. It is especially suited for younger, more active patients. All four patients were up and walking the day after the surgeries. Press Release from the Hospital ASR News Story Canadian TV News Story John Antoniou, MD Further Info on Hip Resurfacing Smith and Nephew to Buy Midland Medical TechnologiesMarch 14, 2004Smith and Nephew announced Friday, March 12 it will purchase Midland Medical Technologies for $120.4 M cash, plus future payments of up to $60M depending on meeting regulatory milestones. Midland Medical Technologies is a leading maker of metal-on-metal hip resurfacing components. Their Birmingham Hip Resurfacing, BHR, is the largest selling hip resurfacing component, with over 27,000 BHR hips implanted worldwide. Smith and Nephew is diversified health care manufacturer and one of the world's largest maker of orthopedic implants. Smith and Nephew intends to begin seeking FDA approval for marketing the BHR in the United States. Smith and Nephew Press Release Midland Medical Technologies Biomet Antibiotic Bone Cement Approved by FDADecember 18, 2003Biomet Corporation has received FDA approval for its Palacos G brand antibiotic-loaded bone cement. Gentamicin is added to their standard Palacos bone cement for the purposes of prevention of further infections in two-stage total hip revisions necessitated by an infection on the original hip replacement prosthesis. Biomet Press Release Biomet Home Encore Ceramic-on-ceramic Hip Replacement Approved by FDADecember 1, 2003Encore Medical Corporation has received FDA approval for its Keramos brand Ceramic-on-ceramic hip prosthesis. The company is the third to market a ceramic-on-ceramic hip, following Wright Medical Technology and Stryker Corporation, who both began marketing in the United States in February, 2003. Encore has annual sales of about $100 million. Encore Press Release Encore Medical Homepage Zimmer to Acquire Implex CorporationNovember 25, 2003Zimmer Holdings, Inc announced it had reached an agreement with Implex Corporation to buy the company for $108 million dollars in cash and stock. The acquisition is expected to be finalized in the first quarter of 2004. Implex is privately held.
Previously Zimmer had an agreement with Implex to market and develop applications for Implex's Hedrocel trabecular metal. Hedrocel is a porous form of tantalum metal that mimics human bone.
Study on Hip Resurfacing Accepted by JBJSOctober 19, 2003A study on the first 400 Wright Medical Conserve Plus Metal-on-Metal Hip Resurfacing components has been accepted for publication by the editors of the Journal of Bone and Jone Surgery (JBJS). The study, led by Dr. Harlan Amstutz of the Joint Replacement Institute of the Los Angeles Orthopaedic Hospital, reports a low incidence of failure, which declines in each successive series of one hundred patients. Improvement in results is attributed to an improvement in patient selection and improved fixation techniques. An index of risk is developed to guide surgeons in proper patient selection. The study will be published soon in JBJS. An excerpt of the paper was provided to ActiveJoints.com and and is available in pdf format through this link. Joint Replacement Institute Journal of Bone and Joint Surgery Hip Patient Authors BookOctober 19, 2003Hip patient Peggy Gabriel has published a book describing her story of research into choices in hip surgery and what led her on a path to travel from the United States to Belgium for surgery on both her hips. A few months after surgery she was able to return to her career, and she found that surgery not only restored a spring to her step, but her back pain resolved because her gait returned to normal. The author details the road to her recovery and how she was able to find information and support online.
Ms. Gabriel's book is entitled,
Hip Replacement or Hip Resurfacing: A Story of Choices, and
it is available directly from the publisher, 1stbooks.com, or from Amazon.com by
clicking here.
Zimmer Completes Acquisition of CenterpulseOctober 3, 2003Marking the completion of the purchase of Centerpulse, Zimmer announced management changes effective today for the reorganized companies. The acquisition was formally completed on October 2, creating the world's largest pure-play orthopedics company. Nine executives were named to lead the companies in their new structure. Details of the management announcements can be found on the Zimmer corporate website. Ceramic Hips Boost Sales at Wright and StrykerAugust 13, 2003Sales of ceramic hips boosted sales in the second quarter at Wright Medical and Stryker according to statements filed with their second quarter financial results in July. Domestic hip sales increased 44% at Wright, and Stryker Corporation reported 21% domestic hip sales growth for the quarter. The second quarter was the first full quarter for sales of the ceramic-on-ceramic hips that received FDA approval for marketing the in United States in February.
F. Barry Bays, President and CEO of Wright Medical commented in a press release issued by the company, "Our record second quarter sales results were driven by outstanding growth in our hip product line, reflecting the continued exceptional success of our LINEAGE(R) ceramic-on-ceramic hip system as well as our CONSERVE(R) Total hip system with BFH(TM) Big Femoral Head technology, both launched during the first quarter."
John Brown, Chairman and CEO of Stryker commented in the company's telephone conference call with analysts, "The second quarter introduction of the ceramic insert for the Trident hip system had an extremely positive impact on sales in the quarter."
Zimmer Makes Offer to Purchase CenterpulseMay 20, 2003Zimmer Orthopedics made an offer to buy Centerpulse Orthopedics (formerly Sulzer Orthopedics) for cash and stock valued at $3.2 Billion, topping Smith and Nephews recent $2.3 Billion bid for the company. The combined company would be the largest orthopedic company in the world.
The board had previously approved a merger with Smith and Nephew and will now consider this offer. Shareholders had yet to ratify the previous merger plans.
Smith+Nephew to Acquire CenterpulseMarch 20, 2003Smith and Nephew has made an offer to buy Centerpulse Orthopedics (formerly Sulzer Orthopedics) for cash and stock valued at $2.35 Billion. The combined company will be the third largest orthopedic company in the world. The merged company will go by the name of Smith and Nephew Group. The deal has been approved by the boards of both companies and need only be accepted by a majority of shareholders in a current tender offer.
Shares of Switzerland-based Sulzer fell dramatically a few years ago when the brand was tarnished by the recall of a defective hip replacement shell. The company was renamed Centerpulse just last summer and had been rumored for sale for a number of months. During that time shares rose from a low of $3 US per ADR share to $20.
Ceramic-on-Ceramic Hips Approved by the FDAFebruary 3, 2003In separate statements, Stryker-Osteonics and Wright Medical Technology reported that the FDA had approved alumina ceramic-on-ceramic articulated hips for marketing in the United States. Both companies had been awaiting the FDA manufacturing approval of their supplier of alumina ceramic components, Ceramtek of Germany. Full production and marketing of the ceramic-on-ceramic hips is expected to begin later in the first quarter. More about ceramic hips on ActiveJoints.com Wright Medical Technology Stryker Corporation Zimmer Reports Failures in ZMR ImplantDecember 7, 2002Zimmer Orthopedics has reported 20 cases of breakage of its ZMR hip implant. TTwelve such reports can be found in the FDA's MAUDE database. According to a Reuters report published on Dec 6, 2002, Zimmer does not plan a recall of the product, but has sent a letter to surgeons emphasizing the need for proper proximal support of this product to avoid internal breakage. FDA MAUDE Database, Enter Brand Name=ZMR, Manufacturer=Zimmer FDA Medical Device Application Fees SetOctober 20, 2002The US Senate passed legislation Friday approving application fees for new medical devices. The measure is patterned after a similar rule for prescription medications. The income will be used to hire new personnel, and is expected to speed the approval of new medical devices.
Manufactures will have to pay a "user's fee" of $154,000 for each device approval application. The US House of Representatives previously passed a similar bill.
Ceramtek Inspection Set for NovemberOctober 17, 2002Stryker Corporation President, John Brown, announced this week that the FDA inspection of the Ceramtek manufacturing facility in Germany has beeen slated for November, 2002. The company anticipates the facility will gain acceptance by the FDA following the inspection. This action is the last remaining hurdle standing before ceramic-on-ceramic hips can be approved for marketing in the United States. Osteonics and Wright Medical are set to use Ceramtek as suppliers of ceramic parts for their ceramic hip implants. Contingent on FDA approval of Ceramtek, marketing is expected to begin in early 2003. Stryker is the parent of Osteonics. Full audio of the Stryker conference call can be accessed from the investor relations page of the Stryker Corporation website.
Wright Medical Group is the parent of Wright Medical Technology. Wright has scheduled a conference call for October 28, 2002. Full audio of their conference call can be accessed from the investor relations page of the
Wright Medical website.
Osteonics and Wright Announce Further Delay in Ceramic Hip ApprovalAugust 1, 2002In separate conference calls with their shareholders and investment analysts, Stryker Corporation and Wright Medical Group announced that due to delays in FDA certification of their European supplier of ceramic hip components, FDA approval of marketing for the Osteonics and Wright Trident ceramic/ceramic hips will be delayed until the first quarter of 2003. Originally, approval had been expected in the second quarter of 2001. Stryker is the parent of Osteonics. Full audio of the conference call can be accessed from the investor relations page of the Stryker Corporation website.
Wright Medical Group is the parent of Wright Medical Technology. Full audio of their conference call can be accessed from the investor relations page of the
Wright Medical website.
Sulzer Completes Name Change to CenterpulseMay 30, 2002SulzerMedica, has completed its name change to Centerpulse. It is now listed on the New York Stock exchange with ticker: CEP. This completes its spin-off from parent Sulzer, AG.
The company's new website is www.Centerpulse.com
Sulzer Completes Settlement for Inter-Op PatientsMay 29, 2002SulzerMedica's settlement with the victims of the defective Inter-Op shell is complete and has been approved by the court. Details of the settlement plan can be found at SulzerImplantSettlement.com Corin Announces London Stock Exchange Listing
May 9, 2002 |
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ActiveJoints: Total Hip Replacement and Alternatives
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