![]() population than in other countries, which may influence the outcomes of hip surgery including the revision rate or implant survivorship (need to remove implant and put another in its place). Population – Factors including a patient's age, sex, weight, diagnosis and activity level influence the lifespan of a device.In the U.S., approximately half of all primary hip replacements are performed by surgeons who typically do fewer than 15 to 20 of these surgeries per year. In the U.S., there is greater variety in surgeon experience and hospital volume in comparison to some other countries, where hospitals are more focused on certain types of procedures. Practice of Medicine – Surgeon experience and training programs differ between countries.This could mean patients are treated at a later stage of disease and/or later age, which will impact the device selected for treatment and the outcomes of hip surgery. may wait longer to receive a hip implant. Healthcare System – National guidelines regarding patient eligibility for hip implants can result in differing timeframes between diagnosis of a patient's underlying hip disorder and hip replacement surgery.There may also be substantial differences in the practice of "mixing and matching" implant components between the U.S. Devices used in other countries may not be available in the U.S., and among devices available around the world, device popularity and usage vary. Device Availability – There may be physical differences between a device marketed in the U.S.In June 2012, the FDA asked members of the FDA's Orthopaedic and Rehabilitation Devices Advisory Panel to discuss these differences and the following points were highlighted: ![]() Since much of the available data are from countries outside the U.S., the data are not necessarily indicative of U.S. patients to those in other countries, it is important to be aware of the differences. Although the safety concerns for patients who have MoM hip implants are present throughout the world, there are differences both in device usage and device design of MoM hip implants in the United States and those outside the United States. Much of the available data regarding hip implants, including Metal-on-Metal (MoM) implants, involve registry data from countries outside the United States. Metal on Metal Hip Implants Outside of the United States Information for patients and health care providers about metal-on-metal hip implants is provided in this websection. Patients with a progressing ALTR may be considered for earlier revision to prevent extensive damage to bone, muscle and nerves. This local response is sometimes referred to as an "adverse local tissue reaction (ALTR)" the systemic and local responses are referred to as "adverse reaction to metal debris (ARMD)." Soft tissue damage may lead to pain, implant loosening, device failure, and the need for revision surgery (the old device is removed and replaced with another one). Over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint. At this time, it is not possible to predict who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be. However, there is no way to fully avoid the production of metal ions and some metal particles.ĭifferent people will react to these metal ions and particles in different ways. Orthopaedic surgeons take several precautions before and during hip replacement surgery to try to optimize the way in which the ball and socket rub against each other so that fewer wear particles are produced. cobalt and chromium) from the metal implant or from the metal particles will enter the bloodstream. Wear and corrosion at the connection between the metal ball and taper of the stem may also occur. The sliding metal surfaces will cause some tiny metal particles to wear off of the device into the space around the implant. ![]() Metal can also be released from other parts of the implant where two implant components connect. In MoM hip implants, the metal ball and the metal cup slide against each other during walking or running which can cause the release of metal particles. Metal-on-metal (MoM) hip implants have unique risks in addition to the general risks of all hip implants. All artificial hip implants carry risks including wear of the component material.
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