Following complaints from doctors of a high failure rate, Zimmer has halted the sales of its artificial hip socket. However, the product has not been recalled. Doctors have been reporting that the failure of the Durom cup has resulted in patients having to undergo replacement surgery, Although Zimmer didn’t find the device to be defective, some experienced surgeons have had trouble implanting it, according to The New York Times. In April, a Los Angeles surgeon brought attention to the implant problems in a letter to his colleagues.
Zimmer expects the sales suspension to slash $20 to $30 million from its sales estimates. The company is also stopping its U.S. premarketing trials of a resurfacing system.
–From DeviceTalk
Dang Orthopedics, an orthopedics research lab, is collaborating with university researchers to create an advanced system for analyzing the effects on the spine and shoulder upon exposure to severe movements like whiplash. Creating a computational simulation of the stress put on the cervical spine after surgery could help researchers and doctors understand the biomechanical effects of discectomy and fusion. Dang Orthopedics is working with the University of California, San Francisco, and the New England Musculoskeletal Institute at the University of Connecticut Health Center, and is using technology made by NVIDIA for its graphics. The lab made a model of cervical spine fusion using Toyota’s Total Human Model for Safety (THUMS), which was originally used to simulate the effect of car accidents on the body. Dang Orthopedics is the first orthopedic research lab in the United States to be given an academic license to use THUMS for general orthopedic research. The lab also used the simulation tool LS-DYNA to isolate the biomechanical effects of single- and two- level cervical spine fusion. LS-DYNA was initially created for nuclear weapons development and certification.
The resulting data from the collaborative research will aid further research involving multilevel artificial vertebral disc replacement. Understanding the procedure’s effects also has the potential to lower the incidence and severity of postsurgical complications.
Zimmer Holdings has recalled an instrument used in minimally invasive knee replacement surgeries, reports the Journal Gazette of Fort Wayne, IN. The recall decision was made after the instrument, used with the NexGen knee implant, broke during several surgeries. It is a tibial broach impactor, which helps prepare the tibial bone to accept the final implant component. The NexGen itself is not being recalled. The firm said it has notified FDA and affected customers.
St. Jude Medical has received FDA approval for a RF wireless technology that can remotely monitor an implanted cardiac device. The Merlin @home transmitter works with St. Jude’s current line of RF devices and its data management system, Merlin.net Patient Care Network, which provides remote care services for patients and their doctors. The wireless device allows patients to conduct follow-up checks on their device’s performance, and any data downloaded by the transmitter is sent to the Merlin.net system for storage and review by the patient’s doctor. The device will be launched in the United States in the fall and international in the fourth quarter.
A lawsuit filed against Stryker and Smith & Nephew by three patients charges that they paid more than they should have for artificial knees because the firms participated in a kickback scheme with orthopedic surgeons. The suit accuses Smith & Nephew and three divisions of Stryker of “conspiracy, unjust enrichment, fraud and a `pattern of racketeering’,” reports the Record of Hackensack, NJ. It claims that the firms’ conduct made them an oligopoly, which inflated the prices of the implants and forced patients to pay more out-of-pocket. The suit is a class-action and seeks damages and restitution for anyone who received artificial hips or knees from Stryker or Smith & Nephew.
The Access to America’s Orthopaedic Services Act of 2008 aims to improve awareness of bones, joints, and musculoskeletal health. The legislation was introduced by Congresswoman Hilda L. Solis (D-CA) and Congressman Michael C. Burgess (R-TX) yesterday. It’s also a response to gaps pointed out in the Surgeon General’s report on bone health in 2004. The bill raises concern over the potential insufficient number of doctors in the musculoskeletal field and calls for a study that reviews the amount of available funding for educating and training orthopedic physicians. Solis also said it’s necessary to improve the awareness, prevention, and treatment of musculoskeletal conditions in minority communities.
The legislation would carry out five points of action:
1. Provide Congress with reports to analyze the amount of funding for musculoskeletal research, the number of investigators entering the field, and current federal trauma care initiatives.
2. Urge the Office of Minority Health to consider musculoskeletal conditions as a health priority.
3. Advise the Agency for Healthcare Research and Quality to make recommendations for a standard and low cost technology that measures bone density.
4. Require HHS to conduct public educational campaigns.
5. Increase agency reporting requirements to improve the treatment and management of musculoskeletal diseases across age populations.
Norman Noble Inc., a medical device contract manufacturer, will undergo a major expansion of its orthopedic implant manufacturing operations. The most significant step is the addition of eight five-axis contour milling machines. They will make the firm one of the largest providers of single-operation machining to the orthopedic implant market. Most machining operations for orthopedic implants require multiple steps. The new machines will be able to perform everything in a single step. The firm will also increase capacity in its Swiss turning and milling department, and add equipment to assist in quality inspection.
The company had already begun a $1.7 million expansion of its mass finishing operation, which is also used in orthopedic implant manufacturing. It says it is taking these steps because orthopedic implants are one of the fastest-growing segments in medical device manufacturing.
The orthopedics industry is looking for a way to transmit information from knee, hip or other implants about how the implant is behaving inside the body, reports the Greater Fort Wayne (IN) Business Weekly. RFID could be the solution — and the article profiles Fort Wayne-based RFID start-up Solstice Medical LLC. Orthopedic devices must be balanced when implanted to ensure they are handling pressure properly and working correctly. Sensors imbedded in an implant could transmit that information to a receiver and computer. This kind of technology is already used in pacemakers and hearing aids.
Johnson & Johnson’s DePuy Orthopedics may have a head start on implementing something like this. In June, it received a patent for a wireless communications system. But it may be 5-7 years before a wireless-enabled orthopedic implant clears FDA.
FDA has approved two coronary stents: Abbott’s XIENCE V and Boston Scientific’s PROMUS, both of which are an everolimus eluting coronary stent system. The PROMUS is actually the private-labeled XIENCE V, which is made by Abbott but distributed by Boston Scientific. The stent props open the artery and releases everolimus. According to Abbott, a big part of FDA’s approval of XIENCE V came from favorable results achieved in a clinical trial in which the device showed “statistical superiority” to Boston Scientific’s TAXUS stent. Results of the two-year trial included (both compared to Taxus) a 45% reduction in the risk of major adverse events and a 32% reduction in the risk of target vessel failure.
XIENCE V is built on Abbott’s MULTI-LINK VISION coronary bare metal stent. It has been on the market in Europe for almost two years. Since Boston Scientific provides PROMUS, it is the first U.S. company to offer a dual, drug-eluting stent portfolio.
– From Device Talk
FDA has issued a Public Health Notification about complications related to the use of recombinant human bone morphogenetic protein (rhBMP) in cervical spine fusion, a use that FDA has not approved. At least 38 reports have been received by FDA during the last four years related to rhBMP use in cervical spine fusion. Complications, which could be life-threatening include difficulty breathing or swallowing, and swelling of the neck, tongue, mouth, shoulders, or upper chest. Most of the complications happened between 2 and 14 days after an operation, and some patients required respiratory support and second surgeries to drain the surgical site.
