Indiana-based Biomet is a medical device manufacturer that specializes in implants to replace the hip, knee, shoulder and other joints. In 2010, Biomet’s U.S. hip implant sales were $312.9 million, accounting for 12 percent of the domestic hip implant market. The company has contributed a number of new technologies to the orthopaedic device industry and has expanded to dental implants, bone-healing technologies, and products to treat trauma, sports injuries and spinal injuries.
One of Biomet’s flagship innovations is the proprietary E1 Antioxidant Infused Technology, used in a number of its hip replacement systems, including the Active Articulation E1 Dual Mobility Hip. Products featuring this technology contain polyethylene cup bearings and liners infused with the natural antioxidant vitamin E.
Despite Biomet’s success, it has had its share of problematic devices, specifically the M2a Magnum hip implant products and the Stanmore and Exceed ABT devices with optional metal liners. The problems stem from their metal-on-metal design. MoM hip implants like the M2a Magnum, Stanmore and Exceed ABT can cause a variety of complications, including metallosis, which is metal poisoning that occurs when metal particles are released into the blood from the artificial joint.
The U.S. Food and Drug Administration (FDA) received hundreds of reports of complications from doctors and patients who have used the M2a Hip implant line of products, however, the devices have not been recalled. A number of patients filed lawsuits against the company for complications such as pain in their hips, dislocation and soft tissue damage that necessitated revision surgery.
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Biomet’s Hip Replacement Products
Biomet manufactures hip replacement devices for all types of hip replacement surgeries. These devices include primary femoral and acetabular components, as well as revision components. Revision components are used in surgery to replace faulty or failed implants from the original hip replacement surgery. Biomet’s implants come in a variety of materials such as ceramic, metal and polyethylene plastic. The company claims that components manufactured with its exclusive E1 Antioxidant Infused Technology have a lower wear rate than other polyethylene products.
Biomet also produces a number of metal-on-metal (MoM) hip replacement prostheses — which use two or more metal components. In addition to its popular M2a Magnum line of implants, Biomet manufactures other MoM designs, including the Biomet Stanmore and Exceed ABT . According to Biomet, the company produces the widest range of MoM hip devices in the industry.
They have also improved upon the MoM monoblock component design. Unlike modular hip systems, which include a number of interchangeable parts, the parts of monoblock implants are designed as a single piece. Acetabular monoblock components, which are Biomet’s specialty, come with the liner, cup and ball as one piece; monoblock femoral components come with the ball, neck and stem as one piece.
Monoblock acetabular components are used without screws and are pushed into the hip socket. The porous coating on the outside of these implants encourages bone growth without the need for screws to hold the implant in place. Monoblock acetabular implants do not rely on a locking mechanism to hold the liner in place because the liners are machined into the inside of the cup. Some studies have shown that these one-piece components have less debris buildup because there are fewer moving parts.
Hip Systems, Products and Components
Primary Femoral Components
|Answer Hip System||Balance Femoral Component|
|Bi-Metric Porous Primary Femoral Component||Bi-Metric Interlok Femoral Component|
|Bio-Groove HA Hip System||Biomet Hip Fracture Femoral Component|
|Bio-Moore II Hip System||Generation 4 Polished Hips System|
|Integral Centralizer Femoral Component||Integral Reduced Proximal Profile Femoral Component|
|Rx 90 Smooth Primary Femoral Component||Stanmore Hip System|
|Mallory-Head Interlok Femoral Component||Taperloc Hip System|
Revision Femoral Components
|Bi-Metric Head/Neck Replacements||Reach Revision System|
|Bi-Metric Long Stems||Rx 90 Revision System|
|Integral 180 Femoral Component||Mallory-Head 1pc Calcar Femoral Component|
|PLR Proximal Loading Revision Stem||Mallory-Head Modular Calcar Revision System|
|Reach Modular Revision System||Arcos Modular Femoral Revision System|
Primary Acetabular Components
|Bio-Clad Polyethylene Acetabular Component||C2a – Taper Acetabular System|
|Full Hemisphere Solid Acetabular Component||M2a – Ringloc Liner|
|M2a – Taper Acetabular Hip System||M2a – 38 Metal-on-Metal Acetabular Hip System|
|QSAC Quadrant Sparing Acetabular Component||Ranawat/Burstein Polyethylene Acetabular Component|
|RingLoc Acetabular Liners||RingLoc Acetabular Series|
|RingLoc Bi-Polar Articulating Hip System||Rx 90 Low Profile Acetabular Component|
|Rx 90 Polyethylene Acetabular Component||Tri-Spike Acetabular Component|
|Universal Acetabular Component||Vision Acetabular Component|
|Mallory-Head Radial Acetabular Shell||M2a-Magnum Large Metal Articulation|
Revision Acetabular Components
|Biomet Tri-Polar Acetabular System|
|Freedom Constrained Liner|
|Healey Flanged Revision Acetabular Component|
|Par 5 Acetabular Reconstruction System|
|Recovery Protrusio Cage|
|Mallory-Head +5 Acetabular Component|
|Regenerex Acetabular Reconstruction System|
Biomet’s M2a Magnum Hip Implants
The company released its lucrative M2a line of MoM implants in 1996, beginning with the M2a RingLoc. From 1999 to 2009, more than 110,000 M2a devices were implanted. According to Biomet, the M2a design increases long-term performance, allows for a wider range of motion and decreases dislocation.
|The M2a line includes the following models:|
The M2a Magnum Large Metal Articulation device was released in the Unites States in 2004 and is one of the company’s bestselling devices. Following the release of this device, all M2a implants were consolidated under the M2a Magnum brand. These devices are monoblock implants, and each M2a model has slight differences in design to accommodate different patient needs. The M2a Magnum line includes several acetabular products, all of which are made up of the cup (or shell), metal liner and metal ball. The M2a Magnum products are intended for use with a non-cemented surgical technique and can be used for primary or revision surgery.
In M2a Magnum products, the acetabular (hip socket) cup’s outer surface is coated with porous titanium alloy that encourages bone growth, and the inside of the shell is made of cobalt chromium (CoCr) alloy. All of the components of the M2a Magnum line are metal, and surgeons have the choice of a few stems that are designed to work with this prosthesis.
These implants are designed for active people, and the larger head diameter has the potential for more than 160 degrees of motion. Surgeons also have a wide range of head sizes, allowing them to more closely fit the patient’s anatomy. The downside to these larger heads is that the surface area rubbing against the inside of the cup is larger, and this increases surface wear. This means more metal particles may be released into the blood and surrounding tissues.
The M2a Magnum Large Metal Articilation System is endorsed by former Olympian Mary Lou Retton, who suffered from hip dysplasia and damage to her hips from her career as a gymnast. Retton received a total hip replacement using this device, along with Biomet’s Taperloc Hip Stem, in 2005 at the age of 37.
Problems with the M2a Magnum Metal-on-Metal Hip
The M2a Magnum products may offer greater range of motion and less wear, but the implants are not without their problems. In fact, 450 adverse events have been reported to the FDA by patients and doctors related to M2a Magnum products, and the number will most likely grow. These events include pain, swelling, premature device failure and fracture.
Another problem with the M2a Magnum line is metallosis, which can occur with any metal-on-metal implant. When the metal surfaces of ball and socket rub against each other, they release metal debris. The debris can cause damage in the tissues around the joint, leading to several problems such as tissue discoloration, tissue necrosis (death), pockets of fluid called pseudotumors, groin pain, swelling, and loosening of the prosthesis leading to dislocation or fracture.
The M2a Magnum uses cobalt chromium (CoCr) in the inside of its shell and also for the ball, which can lead to excessive metal particles being released into the blood. Patients implanted with the M2a Magnum have suffered from pain, pseudotumors, extensive soft tissue damage and loosening of the component less than a year after implantation. All of these conditions require revision surgery to correct. In addition, the metal particles in the blood can travel to other organs and cause complications.
Biomet Hip Replacement Lawsuits
The M2a Magnum line was approved for distribution in the United States by the FDA under its 510(k) approval system. This means that it was not tested prior to release, since similar products already existed on the market. Because of the growing number of people developing pain and disability as a result of the M2a Magnum, the number of lawsuits filed against Biomet over the design is also growing.
The judicial panel on multidistrict litigation ordered that the cases be consolidated and transferred to the Northern District of Indiana, where Biomet is headquartered. The panel also noted the growing number of complaints alleging that the metal-on-metal design of the M2a Magnum causes dangerous levels of metal particles in the blood and surrounding tissues. There were more than 300 federal lawsuits against Biomet in May 2013.
The year 2012 was a difficult one for Biomet. In March, Biomet was sued by the Securities and Exchange Commission (SEC) under the Foreign Corrupt Practices Act. The SEC claimed that Biomet and its subsidiaries bribed doctors in Argentina, Brazil and China to use its products from 2000 to 2008. Biomet reportedly kept false records of these bribes, claiming they were “commissions,” “royalties” or “scientific incentives.” The company agreed to pay $22.9 million to settle the charges.