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Biomet M2a-Magnum Metal-on-Metal Hip Replacement
The Biomet® M2a Magnum metal-on-metal hip joint replacement devices are intended for use in non-cemented primary and revision hip joint replacement procedures. The large metal head consists of a CoCrMo (cobalt, chromium, and molybdenum) alloy, three metals that have been used in medical devices for years. The porous coating and taper adapter consist of a titanium alloy believed to aid in bone growth.
According to Biomet, the large head design, along with the alloy, is designed to lead to less wear and corrosion and a smaller volume of debris, which allows a greater variety of sizing options, including larger heads. Larger heads yield greater range of motion and stability, resistance to dislocation, and a better match to each individual patient’s size and stature.
Biomet M2a-Magnum Surgical Options
The Biomet devices can be used in traditional hip replacement surgery. Biomet also worked with a team of surgeons to develop specialized instrumentation and surgical technique to aid in the implantation of their device. The Biomet Anterior Supine Intermuscular (ASI) technique builds on traditional minimally invasive surgery, which allows surgeons to directly approach the hip without having to cut through the surrounding muscles and/or tendons in the process.
Biomet Device Options and Variations
Biomet produces a number of products for hip replacement and hip resurfacing procedures, including femoral heads and stems, acetabular shells and liners, intended for use in cementless primary and revision hip replacement surgery.
Although the device is believed to produce only low amounts of debris, it is uncertain how much debris will accumulate over time, or what biological effect that debris will have.
Biomet M2a-Magnum Health Complications
The Biomet M2a Magnum device is subject to similar complications as other metal-on-metal devices, such as inadequate positioning, loosening, fracture of the device, and dislocation. Most of the notable complications pertain to the large head and the metal-on-metal design of the device. There may be the potential for a local tissue reaction due to the presence of the foreign material alone. The clinical relevance of this reaction is not understood at this point. There exists a potential of debris forming over time, along with elevated metal ions formed with the constant rubbing of the surfaces together. Although the device is believed to produce only low amounts of debris, it is uncertain how much debris will accumulate over time, or what biological effect that debris will have.
Biomet Alerts and Warnings
Although there has been no recall, there have been multiple complaints about Biomet devices made to regulatory agencies. Biomet continues to monitor its products through ongoing post-market surveillance. 1
Governmental agencies around the world have advised that surgeons follow up with patients who have metal-on-metal hip implants. Between 2010 and 2012, health agencies in the U.K., Canada and Australia issued various guidelines about metal-on-metal hip implants to surgeons and patients.
In the U.S., the Food and Drug Administration (FDA) recommends that patients with hip implants schedule follow-up visits annually or bi-annually to identify potential issues before they become problematic. Surgeons may perform various tests to identify any potentially negative symptoms of malfunction. 2 The FDA further advises that certain patients, including female patients, are at risk for increased device wear and/or >adverse reactions to metal debris and should be monitored closely.
Biomet. Important Information for Metal-on-Metal Hips: Biomet Orthopedics. Accessed August 11, 2013. ↩
U.S. Food and Drug Administration. Concerns about Metal-on-Metal Hip Implants. (Rev. Jan. 17, 2013). Accessed August 11, 2014 ↩