Who Is Biomet?
Zimmer Biomet is a giant in the joint replacement and surgical products medical device arena. They manufacture products dealing primarily with the musculoskeletal system of the human body which may be used with surgical and non-surgical techniques.
Zimmer was established in Indiana in 1927 by Justin Zimmer. In April 2014, Zimmer agreed to purchase Biomet, a competing company located in the same area. Zimmer specialized in reconstructive orthopedic implants and trauma products. Prior to the acquisition of Biomet, Zimmer had acquired a number of medical products companies including Centerpulse, InCentive Capital, ORTHOsoft, Medizen Technik, Knee Creations, and ETEX Holdings.
Zimmer Biomet remains headquartered in Warsaw, Indiana. The company has expanded a number of times through additional acquisitions including Ortho Transmission, Cayenne Medical, LDR Holding, CD Diagnostics, and Clinical Graphics. The company and its subsidiaries have thousands of employees, distribute products to approximately 90 countries, and have an estimated annual revenue of about $8 billion.
What Products Does Biomet Make?
Biomet specialized in hip & knee products, extremity products, surgical products, bone cement & accessories.
What Are Biomet Hip Replacement Devices?
Biomet offers many hip replacement devices that span from fracture to replacement to reconstruction devices.
Those Devices are:
- ONE Planner® Hip
- Vivacit-E® Vitamin E Highly Crosslinked Polyethylene
- Longevity® Highly Crosslinked Polyethylene
- Trabecular Metal™ Technology
- OsseoTi® Porous Metal™ Technology
- Echo® Hip System
- Avenir Complete™ Hip System
- Taperloc® Complete Hip System
- Exodus Revision Hip System for Femoral Stem Removal
- G7® Acetabular System
- Arcos® Modular Femoral Revision System
- Arcos® One-piece Femoral Revision System
- Wagner SL Revision® Hip System
- Trabecular Metal™ Acetabular Revision System
- Triflange Acetabular Component
- Move Forward™ 3D Motion Simulation Service
What Is a Hip Replacement?
Hip replacement is a surgical procedure which replaces part or all of a hip joint with artificial components. It is also referred to as hip arthroplasty. Manufactured devices replace a portion of the joint in a partial hip replacement or the entire joint in the case of a total hip replacement. The synthetic replacement parts mimic the natural hip joint. Hip replacement may be performed to relieve pain due to a diseased or damaged joint, improve the function of the joint, and increase mobility.
What Is the History of Hip Replacement Surgery?
Hip arthroplasty is a procedure that revolutionized the medical field. There are over 100 years of history of total hip replacement surgeries.
What Is the Early History of Hip Replacement Surgery?
The earliest recorded attempt at hip replacement surgery was in Germany in 1891. Professor Themistocles Glück recorded using ivory to replace joints in patients whose joints have been destroyed due to tuberculosis. Surgeons took these findings and began to utilize various tissues (skin, pig bladders) between hip surfaces.
In 1925, American Surgeon, Marius Smith-Peterson, created the first mold arthroplasty out of glass. Unfortunately, the forces of the hip movements shattered the glass mold. Marius Smith-Peterson, along with Philip Wiles, continued practicing with this mold until they found the best material, a form of which is still used in modern-day hip replacement devices, stainless steel.
When Was Hip Replacement Surgery Revolutionized?
The first surgeon to use the metal-on-metal prosthesis regularly was George McKee in 1953. This method had a 74% survival rate and eventually grew unpopular due to metal particles being seen in patients during revision surgery for prosthetic failure.
The orthopedic surgeon, Sir John Charnley, is considered the father of the modern THA. His low-friction arthroplasty consisted of three parts; a metal femoral stem, a polyethylene acetabular component, and acrylic bone cement. It was called the low friction arthroplasty as Charnley suggested the use of a small femoral head to reduce wear due to its smaller surface area. This is almost identical, in principle, to the prostheses used today.
Currently, over 75,000 joint replacements are performed each year. There are a variety of techniques currently being used in an attempt to find the combination that yields the fewest complications and the best long-term survival.
What Are Common Products for Hip Replacement?
The following are the famous and commonly used hip products:
- Active Articulation™ Dual Mobility Hip System
- Arcos Modular Femoral Revision System
- G7™ Acetabular System
- ReCap Femoral Resurfacing System
- Regenerex porous Titanium Construct
- Signature™ Hip Technology Personalized Patient Care
- Taperloc Complete Hip Stem
- Regenerex RingLoc + Modular Acetabular System
- E1 Antioxidant Infused Technology
- Echo™ Hip System
- M2a-Magnum™ Large Metal Articulation
- Biolox delta Ceramic Femoral Heads
When Would Someone Need a Hip Replacement?
As hip replacement surgery is invasive and life-altering, doctors may recommend other forms of treatment before electing for a surgical procedure.
Common treatment forms and ways to alleviate hip pain include:
- Physical therapy
- Steroid injections
- Anti-inflammatory medications
However, if the pain still persists, doctors might recommend hip replacement surgery.
Some of the signs that may be used to indicate hip replacement surgery will be advised include:
- Chronic hip pain
- Routine tasks becoming more difficult
- Acute hip stiffness
- Grating or rubbing
- No other treatments work.
- Hip joints are damaged or arthritic
- Reduced mental well-being
What Diseases Could Damage the Hip Joints?
There are many conditions that may cause damage to the hip joints, such as:
- Rheumatoid arthritis
- Traumatic arthritis
- Trochanteric bursa
- Iliopsoas bursa
- Avascular necrosis
- Hip pointer
What Do Hip Replacement Devices Treat?
Hip implants are intended to restore mobility and relieve pain associated with arthritis and other hip diseases or injuries.
Specific injuries and diseases that hip replacements may treat are:
- Rheumatoid arthritis
- Arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia;
- Treatments of non-union
- Femoral neck fracture
- Fractures of the trochanter of the femur, along with head involvement
- Fracture-dislocation of the hip
- Correction of deformity
What Is Arthritis?
Arthritis is not a singular disease and is an umbrella term that encapsulates more than 100 types of joint inflammation and related conditions. This term refers to joint pain or diseases within the joints. People of all demographics live with arthritis. It is the leading cause of disability in the U.S. and is seen commonly in women and older people. Common arthritis symptoms may include swelling, pain, stiffness, and diminished range of motion in the joints.
What Is Osteoarthritis?
Osteoarthritis is a common form of arthritis and tends to affect people as they age. It occurs with the degeneration of the joint cartilage and may cause changes in the bones underlying the joint. There is no known cause of osteoarthritis, but genetics, stress on the joints, and local inflammation are contributing factors.
Which Joints Are Most Commonly Affected by Osteoarthritis?
Osteoarthritis typically occurs in the:
However, arthritis may impact any joint in the body.
What Are the Common Symptoms of Osteoarthritis?
The most common symptoms of osteoarthritis include:
- Bone spurs
- A grating sensation
- Reduced flexibility
What Are the Risks of Hip Replacement?
Hip surgery, like all surgeries, has risks. Risks of hip replacement surgery may include:
- A reaction to the anesthesia
- Heart attack
- Wound infections
- Excessive bleeding
- Blood clots
There may be adverse events after surgery including:
- Hip dislocation
- Bone fracture
- Joint infection
- Local nerve damage with numbness or weakness
- Device loosening or breakage
- Difference in leg lengths
- Bone loss
There are other symptoms that may occur months after the surgery.
These symptoms may indicate that the device is not functioning properly:
- Pain in the groin, hip, or leg
- Swelling at or near the hip joint
- A limp or change in walking ability
- Noise (popping, grinding, clicking, or squeaking) from the hip joint
What Are the Signs of a Failing Hip Replacement?
Although hip replacement surgery has become increasingly popular and successful, failure of the surgery does occur.
These failures may be caused by many factors, including:
- Damage or wearing down of the manufactured products
- Loosening of the implant from the bone
- Bone loss
- Malfunctioning product
- Surgical error
Indications that your hip replacement is failing may include the following:
- Damaged bone tissue
- Unrelieved joint pain
- Lack of flexibility and movement
- Difficulty walking
- Instability in the joint
- Hip dislocation
What Are Biomet M2a-Magnum Devices?
Zimmer Biomet offers seven different metal-on-metal implant devices. The prototype metal-on-metal hip implant was first introduced in May 1996 under the trade name, “M2a-RingLoc”. It was followed by the M2a-Taper, ReCap-Femoral, and M2a-Magnum.
M2a-Magnum Devices are metal-on-metal hip implants. Biomet manufactures metal-on-metal implants using Cobalt and Chromium metals.
The M2a-Magnum device includes both femoral and acetabular components. The total hip joint is replaced by metallic parentheses. An acetabular capsule is prepared on the pelvis and the complementary femoral component is properly placed in the shaft of the femur. These two surfaces articulate to produce a wide range of motions similar to the natural hip joint.
Did the M2a-Magnum Devices Cause Side Effects?
All surgeries and procedures may have common side effects such as pain and soreness of the affected area. However, the Biomet M2a-Magnum Hip System has come under scrutiny for many adverse health issues which may be related to the implant devices.
These issues are caused by the metal debris from the hip implants:
- Tissue death
- Elevated blood metal levels
- Pain and burning
- Vision loss
- Hear Damage
- Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesions (ALVAL)
- Adverse Reaction to Metal Debris (ARMD)
What Is Metallosis?
Metallosis is the deposition of metal debris which can result from shaving off metals by frictions and which may cause increased blood concentration of metals. In a recent study, it was demonstrated that almost all patients suffer from severe metallosis after 10 years of metal-on-metal implants.
What Are Pseudotumors?
A pseudotumor is a large, solid, or semi-liquid mass of soft tissue growth inside the body, often around the hip joint. Pseudotumors may be formed as a negative reaction to metal debris. The main symptoms are pain, swelling, and clicking at the hip site. These lesions or masses are not considered malignant and hould not be confused with cancerous tumors. However, they may pose serious health problems.
When Is Revision Surgery Due to Device Failure Needed?
There are a variety of problems that may require revision surgery. Mechanical failure, infection, and recurrent hip dislocation may prompt a doctor to suggest revision surgery. Often the revision surgery is more dangerous than the initial surgery and may further damage the area of the implant.
Which Biomet Hip Replacements Have Been Recalled?
Orthopedics manufacturer, Zimmer Biomet has been required to issue recalls for some of its hip implant devices due to a high number of adverse events and injuries. Notable Zimmer hip recalls have included the Zimmer Durom Cup and more recently, certain models of the Zimmer M/L taper with Kinectiv technology. The M2a-Magnum device was never recalled. This lack of recall, led to lawsuits which claimed that recipients of this hip replacement were never made aware of the dangerous, adverse effects.
Were Metal Components Responsible for Failures?
Problems with the M2a-Magnum devices have reportedly occurred mainly due to the metal-on-metal construction. Though the Metal-on-Metal design is intended to be a more durable option, severe problems may have resulted from the potential grating of metal surfaces against one another. Grinding of the metal surfaces may have allowed for local tissue destruction and systemic metal poisoning in some Biomet hip implant recipients.
The Metal-on-Metal construction may have played a significant role in the need for the recall of Biomet hip implant products.
What Biomet Hip Replacement Lawsuits Are There?
Biomet has faced thousands of lawsuits in regard to its hip replacements, particularly with its M2a Magnum and Durom Cup devices. These lawsuits are considered defective product lawsuits, specifically the design defects category. This says that even though the product was made as intended, the end product contains defects which may still endanger the user. A product may be dangerous if it does not perform as expected when used in its intended manner.
What Biomet Hip Replacement Lawsuit Settlements Were There?
More than 2,800 Biomet Hip lawsuits were filed over the Biomet M2a-Magnum devices. Federal cases for Biomet Hip Implant injuries were consolidated in multidistrict litigation (MDL) in 2012. Though the cases were set to begin in 2014 in the U.S. District Court for the Northern District of Indiana, the company offered $56 million to settle over 1,140 cases for up to $200,000 each.
Biomet has faced charges with the Securities and Exchange Commission (SEC) regarding violations of the Foreign Corrupt Practices Act. The company was found to have bribed doctors in Argentina, Brazil, and China to use its devices and paid $22.9 million in 2012 to settle the charges.
Though Biomet has offered settlements to thousands of plaintiffs, many lawsuits have not been settled. Not all potential lawsuits will qualify for a settlement as each case is different and evaluated individually.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.