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Hip Replacement Complications

Hip replacement or “hip arthroplasty” is performed to correct hip pain and restore function by replacing worn or damaged hip joints with a new, artificial implant. Hip replacement is a common procedure, performed on more than 320,000 people annually, and an estimated 2.5 million Americans are living with artificial hip joints.

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Common Causes of Hip Pain

Osteoarthritis

Time or age-related wearing of the hip joint which results in lost cartilage and inflammation of the joint tissue.  Without adequate cartilage, bones may grate against one another, making movement difficult and painful.  Most common in people over the age of 50.

Rheumatoid arthritis

An auto-immune disorder.  Inflammation-based damage to hip joints caused by an immune system “attack” on joint tissue.  May affect both young and older adults.

Post-traumatic arthritis

Cartilage damage that occurs after the joint is damaged by a trauma-related fracture or serious injury such as car accident.

Avascular Necrosis

Damage to a hip joint caused by injury or disease, such as cancer, which restricts blood flow to the femoral head.  Without an adequate blood supply, bone tissue will die or “necrose’ and collapse.

Childhood Hip Disease

Hip problems that occur in childhood may result in improper development or irregular formation.  Even when treatment during childhood is considered successful, pain may develop during adulthood.

As the body ages, degradation of the hip joints may cause pain and loss of function.  In some cases, hip pain may become severe and limit mobility.  Though some people experience pain relief through non-surgical treatments such as medications and physical therapy, some patients will require surgery to correct the hip damage.  Surgical hip replacement options may include hip resurfacing, partial hip replacement or total hip arthroplasty.

Hip Joint Damage and Hip Pain

The hip is one of the most complex joints in the body.  It is constructed of a ball-and-socket joint which connects the trunk to the leg.  The “ball” on the top of the large, leg bone or femur is known as the femoral head and fits into the “socket” on the pelvis and is also called the acetabulum.  When healthy, the hip joint is lined with smooth, flexible cartilage and filled with synovial fluid which allows for smooth and continuous movement.

Over time, these tissues may become worn and damaged or degraded.  In some cases, certain disease states may also cause premature wearing of the hip joint.  When this occurs, movement may become difficult and result in significant hip pain.

Hip pain may be caused by damage from arthritis, inflammation, injuries or from simple wear and tear which occurs over a lifetime of use.  The interior of the hip joint may become worn and rough, resulting in painful movement.  In some cases, degradation may become severe enough that the femoral head and acetabulum bone surfaces grate against one another.

Hip pain may make movement difficult and in severe cases, may result in a loss of mobility and inability to walk.  Non-surgical treatments may include physical therapy, medications, and movement aids but some patients will require surgical intervention to repair or replace the hip joint.

Osteoporosis Hip Replacement

Osteoporosis occurs when bone density is lost, leading to a weaker bone structure that can be “porous” in nature.  Osteoporosis results in bones that are more likely to fracture or break, even when subjected to only mild trauma or stress.  Certain factors increase the chance of getting osteoporosis including genetics, age, gender, diet, and lifestyle, along with some medical conditions and specific medications.  Osteoporosis is often considered to be a factor in a hip fracture which may require a hip replacement.

Statistics:

  • Nearly three-quarters of hip fracture patients are women. About 50% of all women in the U.S. and 25% of men will experience a fracture related to osteoporosis.
  • Hip fracture is the most serious type of osteoporosis-related fracture and occurs in more than 300,000 Americans per year.
  • Most people who experience a hip fracture will require assistance with daily activities and up to 20% of senior-aged hip fracture patients die in the first year following the event.
  • Because the U.S. population is aging, the number of hip fractures that occur each year continues to rise.
  • In women over 45, osteoporosis-related events are responsible for more hospital days than many “common” disorders such as diabetes, heart attack, and breast cancer.

Osteoporosis-related hip degeneration may be more difficult to treat with hip replacement due to loss of “healthy” bone to support the implant.  Certain types of hip replacement devices may be more likely to produce early “failure” through post-surgical fracture or dislocation.

Artificial Hip Joint Placement

Hip replacement surgery is performed when a hip joint becomes worn or painful from age-related causes, overuse, inflammatory or medical causes or injury. Replacing a worn hip joint with an artificial joint can restore mobility and relieve pain.

Hip replacement surgery may be performed as a partial hip replacement to remove and replaced a portion of the hip joint or can be performed as a total hip replacement which removes and replaces the entire joint with artificial components.

Partial hip replacement may be performed on the femur head or “ball” or may be performed on the acetabulum or “socket” portion of the hip joint. In cases which are not as severe, a “resurfacing” procedure may be performed which places an artificial cup in the acetabulum socket and a cap over the ball of the femur head.

Hip Replacement FDA Complaints

Though millions of patients have had mobility restored and pain relieved through a hip replacement surgery, some patients do not have positive results. Hip replacement surgery can result in severe side effects and cause complications that go far beyond the end of the surgery, in many cases, eventually requiring hip revision surgery.

Thousands of reports of complaints and serious adverse events involving several defective or poorly designed hip joints have been received by the FDA.

Hip devices commonly listed in FDA complaints include:

Manufacturer Model
DePuy Orthopedics (Johnson & Johnson) ASR Hip Resurfacing System ASR XL Acetabular SystemPinnacle Hip Replacement System
Stryker Orthopaedics ABG II SystemMetal V40 Femoral Head Rejuvenate System
Zimmer Holdings / Biomet Orthopedics Zimmer Durom Acetabular Component (Durom Cup)Biomet Magnum M2A
Smith & Nephew Birmingham Hip Implant R3 Acetabular System
Wright Medical Technology Conserve Resurfacing SystemConserve Total A-Class Advanced Metal Hip Implant SystemConserve Total Hip Implant SystemProfemure Z Stem Hip Device

Many of the hip replacement device failures have been attributed to Metal on Metal (MoM) design which allows for metal surfaces to grate against one another, potentially producing metal fragments or ions which can be shed into joint spaces or absorbed into tissues and transported in the bloodstream.

Many of these patients who suffered severe complications have filed hip replacement lawsuits

Types of Hip Replacement

Depending on the severity of joint damage or degradation, the severity of hip pain and loss of mobility and other patient factors, there are several options for hip repair surgery.  Options include total joint replacement, partial joint replacement, and hip resurfacing.

Total Hip Replacement

Total hip replacement requires the removal of the entire hip joint, including a portion of the femur bone, to be replaced with an artificial joint.  It may be done through a single, large incision or through a newer, less-invasive procedure which utilizes multiple, smaller incisions.

Once the top portion of the femur is removed, it will be replaced with a large stem topped with the “ball” which will slide inside a cup-shaped section attached to the pelvis.  Implants may have components which include metal, ceramic, plastic or a combination and are attached with or without cement, depending upon the design and needs of the patient.

Surgeries performed in the traditional one-incision method may be quicker, requiring less surgery time but may take longer for post-surgical recovery.  The less-invasive procedure may require a longer in-surgery time and may be reserved for younger patients who are not overweight and considered to be healthier.

Partial hip replacement

Partial hip arthroplasty is performed to remove and replace only one portion of the hip joint.  In most cases, the “ball” section of the femur is removed and replaced with an artificial implant, composed of metal or ceramic.  Partial hip replacements are more common in patients who do not have osteoporosis or significant bone degradation but have experienced a trauma of some type.

Hip resurfacing.

Hip resurfacing is a surgical procedure performed to smooth rough or worn joint surfaces.  It often involves placement of a device known as an acetabular cup inside the hip joint and may require a metallic covering be added to the femoral head.

Hip resurfacing or partial hip replacement may sometimes be used to delay the need for a total joint replacement.

Hip implant types

Artificial hip joints are similar in design but may be composed of different materials and are attached or seated by slightly different methods which may or may not involve the use of cement.  Hip implants generally fall into one of the following categories based on component materials including:

  • Metal-on-metal
  • Ceramic-on-ceramic
  • Ceramic-on-metal
  • Metal-on-polyethylene plastic
  • Ceramic-on-polyethylene plastic

Each type of material has characteristics which are both advantageous and disadvantageous, however, the largest number of serious adverse events has occurred in the metal-on-metal hip replacement device category.  Multiple recalls have been issued and thousands of lawsuits have been filed and settled for MoM type implants but many remain in State and Federal courts.

Complications of Hip Replacements

All surgical procedures carry a certain number of risks including adverse events associated with anesthesia, infection, pain and long recovery times.  Hip replacement procedures also carry a number of specific risks of complications, some of which may be serious or even, life-threatening.

Hip replacement complications may include:

  • Nerve damage
  • Bone fracture
  • Bone loss
  • Joint stiffness
  • Joint loosening
  • Joint dislocation
  • Allergic reaction to cement
  • Body-wide inflammation
  • Metal poisoning

Severe side effects or complications of hip replacement surgery may lead to pain, loss of mobility, hospitalization and extended illness due to device failure.

Metal on Metal Hip Replacement

Metal on Metal (MoM) hip implant devices were designed to be longer lasting and more durable than other types of artificial hip joints which are made of metal and plastic. While most MoM device procedures will result in relief of pain and return to mobility, the design of the devices can result in serious medical injuries.

Metal-on-Metal Hip Design Faults

MoM hip replacement devices were intended to be more durable, corrosion resistant and longer lasting to be used in a “younger” patient who was more active. Most were designed as modular systems, intended to make implantation easier and using all metal surfaces to be corrosion and fatigue resistant.

They are constructed of cobalt, chromium and titanium metals which may grate against one another at the joint where the two components meet. This may result in the release of toxic metal ions and debris into surrounding tissues causing a condition known as metallosis. Their design has however proven to be troublesome.

All of the metal-on-metal hip implant devices on the market were approved under a U.S. Food and Drug Administration (FDA) shortcut pathway known as 510(k). This shortcut allows device manufacturers to skip costly and lengthy clinical trials in human patients by claiming that a new device is similar to devices already on the market. Most MoM hip implant devices were never tested in humans before being offered for sale in U.S. patients.

Hip Replacement Metal Corrosion

All hip implants can cause serious side effects, but Metal on Metal devices have been the cause of a higher than average rate of failure due to fritting and corrosion of the metal. When surfaces of metal components grate against one another, metal fragments and ions may be released into the surrounding joint space and may be absorbed by tissues or taken up into the bloodstream.

Metallic fritting and shedding of metal fragments may result in:

  • Metallosis –poisoning due to metal fragments and ions
  • Necrosis – tissue or bone death due to localized reaction to metal
  • Osteolysis – dissolution of dead or necrotic bone tissue, mainly caused by metal toxicity
  • Bone fractures – bones near the joint may weaken and fracture
  • Pseudotumors – false “tumor” formation caused by inflammation which surrounds joint
  • Systemic metal poisoning – body-wide inflammation due to metal ions being taken up into the blood stream
  • Revision Surgery – to remove and replace implant due to pain or severe inflammation
  • Reconstructive surgery – to repair weakened bone tissue resulting in fractures of femur or pelvis

Systemic inflammation or excessive immune response due to body-wide poisoning may cause symptoms such as rash, headache, fatigue or other “flu-like” symptoms.

Metal On Metal Revision Surgery

In many cases of severe metallosis, surgery will be required to correct or treat the complications caused by metal poisoning.

There are two basic procedures that may be needed:

  • Revision surgery will remove the faulty or corroded implant and replace with a new artificial joint, possibly of a different type
  • Reconstructive surgery will repair damage caused by metallosis or a malfunctioning device. Repairs that may be needed include broken bones, degraded or porous bone, necrotic tissue, and damage caused by joint destabilization.

A hip revision surgery is often more complicated than the first joint replacement surgery. Revision surgery, particularly if it involves reconstruction, may result in more pain and post-surgical inflammation and will require a longer recovery period.

Some patients who require revision surgery will need separate reconstruction surgeries, in some cases more than one. Each additional surgery places the patient at greater risk for anesthesia complications, infection risk and will have its own recovery period.

People who must undergo revision surgery due to metallosis will be at even further risk for future complications due to tissue damage and other issues, even after a new joint has been placed as tissue and bone may be weaker and more likely to wear down or fracture.

Other Metal on Metal Hip Side Effects

In addition to serious side effects or complications, patients who receive MoM implants may experience side effects which are less severe such as:

  • Pain and inflammation in hip area, groin and abdomen
  • Mobility difficulties while standing or walking, due to hip instability
  • Loss or atrophy of muscle mass due to joint immobility
  • Loss of function and inability to move due to pain
  • Hip dislocation

Even if side effects are not severe, revision surgery may still be required to restore mobility and relieve pain. Each surgery will carry the same risks for pain and infection and other complications.

Metal on Metal Hip Lawsuits

Stryker Corporation is facing numerous lawsuits for injuries related side effects of its hip implant devices. People or loved ones of those who have been injured, required revision surgery or experienced severe side effects due to a Stryker hip implant should seek legal assistance.

Hip Implant Revision Surgery

Some patients who experience complications after hip replacement will require a revision or repair surgery to remove a defective device, repair damage that may have occurred and potentially implant a new device.  In some cases, repair and reconstruction may require multiple surgeries, damage may be severe and result in permanent disability.

Hip Implant Recalls

There are multiple hip implant devices available on the market and are manufactured by a number of companies.  The most common hip replacement products come from manufacturers including

  • Stryker Orthopaedics
  • Zimmer Holdings and Biomet, acquired by Zimmer
  • Dupuy Orthopaedics, subsidiary of Johnson & Johnson
  • Smith and Nephew
  • Wright Medical Technology

The Food and Drug Administration (FDA) has not issued a general recall for metal-on-metal devices, however multiple models have been recalled by their manufacturers.  All of the largest manufacturers have recalled at least one hip implant device and in some cases, multiple products have been recalled and discontinued.

Hip Replacement Recalls and Lawsuits

Multiple hip replacement devices named in complaints and lawsuits have been subject to recalls issued by the Food and Drug Administration (FDA). The majority of these devices have been Metal on Metal in structure and were approved under a short-cut FDA process which allowed manufacturers to skip clinical testing by claiming that the new devices were similar to devices already on the market.

Hip replacement lawsuits have cited a number of common injuries including need for revision surgery, permanent disability, and even death. Plaintiffs have sought compensation for losses and injuries including medical costs, lost wages, pain and suffering or for wrongful death if the patient died due to hip replacement device defects.

Companies have been accused of constructing or manufacturing defective or faulty devices, failing to adequately warn the public and medical community about risks, aggressive promotion of the devices and in some cases, paying kickbacks to doctors or surgical centers who use them.

Thousands of lawsuits have been filed because of hip replacement devices which caused medical injuries, the need for revision surgery, permanent disability and even death. Some of these lawsuits have been settled but many more remain in federal, state and local courts and more lawsuits may be expected.

People or loved ones of those who experienced serious side effects or complications due to a hip device failure should seek legal advice.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

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