The ASR Hip System is a one-piece cup and socket that may be used either for total hip replacement (ASR XL) or hip resurfacing (DePuy ASR). The ASR Hip System, was designed in conjunction with expert surgeons to respond to a medical need for an implant option with reduced risk for dislocation that supported the active lifestyles of younger patients. Before the ASR Hip System was launched, it was thoroughly tested, and after it was on the market, DePuy continued studying and closely watching how the device was performing.
Note: The DePuy ASR™ Hip Resurfacing System was only approved for use outside the U.S. and the ASR™ XL Acetabular Hip System was available worldwide. For more information on the total hip replacement and hip resurfacing products, please click here.
DePuy experts responded to a medical need for an implant option with reduced risk for dislocation that supported the active lifestyles of younger patients.
- More than 10 years ago, DePuy experts responded to a medical need for an implant option with reduced risk for dislocation that supported the active lifestyles of younger patients. Younger and more active patients were considering hip replacement surgery.
- A clinical need existed for a hip bearing surface like metal that reduced the risk of dislocation and was more durable than polyethylene with reduced wear debris but without the fracture risk of ceramic. That was the goal of the ASR design.
- DePuy scientists, in conjunction with an experienced international Surgeon Design Team, set out to design an improved metal-on-metal hip implant that incorporated advances in manufacturing technology with the very best of what was already available.
- It is well documented that all hip implants, no matter what materials are used, experience wear over time and generate wear debris. Metal-on-metal wear can result in the release of ions that can be measured through medical tests. Although there has been theoretical concern over metal ion release from metal-on-metal implants, no definitive data establishes that the level of metal ion release has clinical significance. The FDA has stated: “At the current time, the FDA believes there is not enough evidence in the U.S. demonstrating a correlation between a metal ion level and the presence of localized lesions, clinical outcomes and/or the need for revision surgery.”
- Through the Instructions For Use included with every ASR XL sold in the U.S., DePuy provided information about metal ion debris to surgeons and specifically warned that one of the known risks associated with the ASR XL was metal ion release.
The ASR Hip System was thoroughly tested. In August 2005, the FDA provided DePuy 510(k) clearance to market the ASR XL device.
- The ASR Hip System was thoroughly tested.
- From the beginning, DePuy acted with transparency by publishing its materials testing, design testing, design rationale and deformation testing results.
- DePuy conducted more than 60 tests, including lab tests, fretting tests, wear tests, deflection tests, materials tests, clearance tests, hip simulation tests, torque testing, lever-out testing, scientific calculations, computerized finite element analysis testing, cadaver tests and sawbones tests.
- In accordance with international standards, DePuy ran several five to six month long tests of the ASR XL in hip simulators that ran 5 million cycles of motion, representing two and a half years of use by a patient. But because the company wanted to better understand the long-term survivorship of the hip, DePuy also ran some tests that exceeded the international standard, running up to a 15 million cycle test.
- Following years of testing, the ASR Hip System was also cleared for sale by regulators in various countries around the world.
- DePuy did not run clinical trials on the ASR XL prior to launch because DePuy had clinical experience with other metal-on-metal products, as well as from ASR devices implanted in international markets for a year and a half prior to U.S. launch of the ASR XL.
- During the U.S. Food and Drug Administration’s (FDA) 18-month review of DePuy’s 510(k) submission, and after receiving from DePuy a complete study of the medical literature at the time, the FDA determined that ASR XL could be cleared under 510(k). In August 2005, the FDA provided DePuy 510(k) clearance to market the ASR XL device.
- To learn how DePuy tests implants, click here.
After the ASR Hip System was on the market, DePuy continued studying and closely watching how the device was performing.
- After the ASR Hip System was on the market, DePuy continued studying and closely watching how the device was performing. There was extensive discussion within the company on product performance and decisions were made based on the company’s knowledge at the time.
- The company looked at data from a variety of sources across the globe and sponsored studies where doctors monitored patients and reported their ASR data.
- At every step of the way, the company carefully considered the data on ASR and actively engaged with surgeons about their general feedback on the ASR system.
- DePuy actively promoted the investigation of alleged issues with both the ASR Resurfacing and ASR XL total-hip devices, and it remained responsive to surgeon feedback. DePuy carefully considered complaints about its ASR hip system through its Health Hazard Evaluation (“HHE”) process, an intensive process in which the company’s Quality Department brings together a cross-functional team to investigate an issue and determine what action, if any, needs to be taken.
- Before August 2010, each of the four HHEs conducted by the company relating to the ASR Hip System concluded that the device was performing acceptably overall and led to the company taking actions it deemed appropriate given the available information at the time, including the initiation of a surgeon training effort to reinforce awareness for proper positioning of components during surgery.
In 2010, DePuy received new information from the National Joint Registry of England and Wales reporting that some ASR patients were undergoing a second hip replacement surgery sooner than expected.
- In 2010, the company received new information from the National Joint Registry of England and Wales reporting that some ASR patients were undergoing a second hip replacement surgery sooner than expected.
- After receiving this information, the company acted quickly by voluntarily recalling the DePuy ASR Hip Resurfacing System and the ASR™ XL Acetabular Hip System in every country where it was sold.
- Before August 2010, the totality of the data available to the company showed ASR was performing consistent with the class of monoblock metal-on-metal hip implants.
- We regret that the product did not perform as expected for some patients, and we understand the recall has been concerning for ASR patients and health care providers. The recall decision was made because we felt an obligation to make surgeons and patients aware of the reported revision rates so surgeons could appropriately evaluate and follow-up with patients.