DePuy Hip Replacement

DePuy Synthes, a major manufacturer of orthopedic products, created three of the hip replacement systems that have shown unusually high failure rates. These systems, The Pinnacle Hip Replacement System, ASR XL Acetabular System, and ASR Hip Resurfacing System, are facing legal issues from implant patients.

Both the DePuy Pinnacle and ASR hip implant systems were created to increase mobility and last longer than other hip implant systems. These types of hip replacement products are designed for a younger demographic of patients who wish to maintain an active lifestyle and need an implant that will last for a longer period of time. Despite the intentions in the design, both systems have a high failure rate and have been linked to serious complications.

Two of these systems were recalled in 2010. The other was never recalled, but it was discontinued in 2013. Both systems have been the subject of thousands of state and federal lawsuits.

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Who Is DePuy Synthes?

DePuy Synthes (DePuy), the first orthopedic product manufacturing business in the world, was created in 1895 and is a subsidiary of Johnson & Johnson. DePuy develops numerous products used in orthopedic procedures. DePuy was acquired by Johnson & Johnson in 1998. In 2012, Johnson & Johnson acquired Synthes and integrated it with DePuy. DePuy has created hundreds of successful orthopedic products.

The company boasts of having one of the most extensive arrays of orthopedics products in the world. It manufactures products in several specialties, including hip replacement, and most of its products have been successful. DePuy invented the first hip replacements.

Unfortunately, three of the DePuy products have caused numerous medical injuries and resulted in thousands of lawsuits. These three products are the DePuy Pinnacle, ASR Hip Resurfacing, and ASR Acetabular System. Some of these systems were designed as metal-on-metal (MoM) construction.

What Is the DePuy Pinnacle Hip Replacement?

The DePuy Pinnacle Acetabular Cup System is a modular cup system designed to optimize the range of motion and maximize stability. This system was designed to meet the needs of younger patients electing to undergo hip replacements at younger ages. The DePuy Pinnacle System was intended to restore function, reduce wear, and improve stability for those younger patients leading increasingly active lifestyles.

The acetabular cup is a portion of the hip implant that is set in the acetabulum portion of the hip bone and acts as the “socket” of the hip’s ball and socket joint system. The liner sits over the top of the femoral head which is the “ball” portion of the hip joint. This system was designed to be highly customizable to the patient, with various options made to fit different individuals.

In the Ultamet Pinnacle system, both components of the Pinnacle hip joint are metal, and this has led to complications in some patients who received this hip joint.

Was the DePuy Pinnacle Hip Replacement FDA-Approved?

The Pinnacle was approved by the FDA in 2000. It followed a near-identical device, the Ultima device, which has also shown a high rate of revision surgery. The Pinnacle was approved through the FDA’s 510(k) program which allowed the company to avoid lengthy and costly clinical trials required for most medical devices. There was no safety testing for this device.

Was the DePuy Pinnacle Hip Replacement Recalled?

The DePuy Pinnacle hip replacement devices were never recalled. DePuy would have been required to give a reason for a recall, so it instead discontinued the Pinnacle system in mid-2013. Discontinuation allows the manufacturer to avoid an admission of defects.

What Is the DePuy ASR Hip Replacement System?

The DePuy ASR Acetabular System is a modular system designed to mimic the natural ball and socket joint of the hip. This system was designed to be used in total hip replacements.

The ASR system is a metal-on-metal system, just like the Pinnacle, and was championed by DePuy and Johnson & Johnson as a technologically advanced system that:

  • preserved bone,
  • enhanced surgical precision, and
  • advanced implant performance.

The DePuy ASR XL Acetabular total hip replacement and the ASR hip resurfacing system were used in over 93 thousand hip replacement procedures. Both products were part of a large-diameter design class which reportedly increased stability and mobility in patients who received the implants. They were also created from a single sheet of metal which was molded rather than cast. This was to increase durability.

The ASR System was designed for use in:

  • patients younger than 65 years of age and
  • patients older than 65 years of age who participated in activities that could shorten the lifespan of a traditional hip replacement.

DePuy intended the ASR System to be used when a patient experienced the following conditions:

  • Painful or disabled joint – caused by osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia
  • Avascular necrosis of the femoral head
  • Acute traumatic fracture of the femoral head and neck
  • Previous hip surgery failure
  • Some cases of ankylosis

The ASR XL system was used in the US for total hip replacements, while the ASR resurfacing system was only used outside of the US. Within five years of implantation, up to 40 percent of patients may have required revision surgery.

Some of the problems caused by the ASR systems have been identical to issues caused by the Pinnacle and prior Ultima Systems manufactured by DePuy.

Was the DePuy ASR Hip Replacement System FDA-Approved?

Like the Pinnacle, the ASR XL Acetabular System was approved by the FDA for use in the US in 2005 using the FDA’s 510(k) program, so there was no testing for the safety of this device.

DePuy attempted to have the ASR resurfacing device approved but it did not qualify for the 510(k) program and the application was recalled due to issues with the clinical trials which showed femur fractures. Despite the known clinical failure, ASR resurfacing devices continued to be sold outside of the US.

Although it was not approved in the US, physicians could use the device obtained elsewhere for “off-label” use. Unfortunately, off-label procedures are treatments are not well-tracked here in the US, so it is not known how many of the ASR resurfacing products may have been used and the lack of tracking made it difficult for physicians to be aware of problems with the resurfacing system which had begun to fail.

Was the DePuy ASR Hip Replacement System Recalled?

In 2009, DePuy voluntarily pulled the ASR resurfacing from the Australian market but made no changes in the total hip replacement system and phased the resurfacing device out in 2010. No changes were made in the total hip replacement system though international tracking showed that both ASR systems had a higher-than-normal failure rate and DePuy focused most of the attention on the resurfacing products alone.

In August 2010, DePuy announced a worldwide recall of both ASR products.

Can MoM Implants Cause Complications?

All hip implants and total hip replacements come with risks, but metal-on-metal implants have additional, unique risks. With metal-on-metal implants, each part – the metal ball and the metal slide – rub against each other when the hip is in use, like when walking or running. When each metal component rubs against the other, metal particles are released. These metal particles are released into the area around the implant, and those particles can sometimes enter the bloodstream. Metal-on-metal implants also carry the risk of wear and corrosion.

As time passes, the metal particles that are released can poison and damage the tissue and/or bone surrounding the implant. This is known as metallosis.

This can lead to the following symptoms/complications:

  • pain,
  • loosening of the implant,
  • implant device failure, and/or
  • revision surgery.

If the damage to tissue/bone continues to progress, the patient can be at risk for considerable damage to their bone, muscle, and/or nerves.

The DePuy devices are also suspected of causing brain and heart damage due to the proprietary composition of the alloy which contains chromium, cobalt, and molybdenum – known to be toxic to the human body, particularly nerve and muscle tissue.

Metallosis injury can sometimes be remedied with revision surgery, however, that type of surgery often requires reconstruction of bone tissue and is much more invasive and requires a longer rehabilitation time than the original surgery. Systemic or body-wide toxicity caused by the absorption of chromium, cobalt, and molybdenum metal ions is likely permanent and is life-threatening in many cases.

Not all patients with metal-on-metal implants will have adverse reactions.

Did DePuy Hip Replacements Cause Complications?

The severe side effects caused by the DePuy hip devices are primarily a result of a faulty design. The devices were manufactured to offer customization for each patient and the ball-and-socket components of the devices were available in combinations of ceramic, polyethylene, and metal. A high number of patients found that the metal-on-metal option could result in severe DePuy side effects.

Most modern hip implant devices were approved under the Food and Drug Administration’s 510(k) device exemption. The 510(k) Premarket Notification Process allows medical devices to forgo stringent and costly clinical testing by claiming that devices are enough like other approved medical devices and that testing is not needed. Because of this 510(k) approval, DePuy hip implants had not been tested in humans prior to marketing for public use.

What Are Some of the Less Serious Side Effects?

DePuy hip implants may cause a number of side effects that are not medically serious. These side effects may impact the patient’s quality of life and ability to perform normal activities. These side effects include:

  • Pain and inflammation in the area surrounding the implant
  • Hip instability or hip dislocation causing difficulty with walking or standing
  • Muscle atrophy due to immobility

What Are Some of the More Serious Side Effects?

  • Metallosis – metal fragment and ion release causing toxicity
  • Necrosis – bone and other tissue death from metallosis toxicity
  • Osteolysis –bone dissolution due to metallosis poisoning
  • Systemic metallosis – whole-body inflammation from metal ions
  • Pseudotumors – formation of tumor-like deposits surrounding affected joints
  • Bone fractures – weakening and breakage of bones surrounding the hip implant
  • Revision Surgery or Reconstructive Surgery– to replace implant or reconstruct bones surrounding the injured joint (femur and pelvis)

Did the DePuy Hip Implants Cause Severe Adverse Events?

There is a risk for more severe complications due to DePuy hip implants. These are known as serious adverse events, and those caused by the DePuy implants include:

  • Metallosis – local toxicity caused by particles of metal that have been shed from the implants and are deposited into body tissues.
  • Osteolysis and necrosis – the dissolution of the bone tissue and death of bone and surrounding tissues due to metallosis poisoning. This is due to direct poisoning but also due to an inability of the body to supply oxygen and other nutrients to the area. Death and dissolution of bone tissue may result in the requirement for bone reconstruction during revision surgery as bone tissue does not easily grow back.
  • Periprosthetic fractures – fractures in the surrounding bone, usually the femur neck. This was the primary reason why the ASR Resurfacing implant was not introduced to the US as clinical studies showed a high incidence of Periprosthetic fractures.
  • Pseudotumors – large collections of solid or semi-solid mass around the implant which cause inflammation, pain, and restricted movement
  • Extreme Pain and Inflammation – Pain is likely the common symptom of adverse reactions to the ASR and Pinnacle hip replacement products. This is due to the metal fragments that may be shed by the metal-on-metal design which causes inflammation and pain.
  • Hip Revision Surgery
  • Systemic metal poisoning – caused by chromium, cobalt, and molybdenum which has been shown to be higher than normal in laboratory results of some patients who have received the DePuy devices. This has resulted in claims of brain damage, cancer, and cardiac damage.

What Is Revision or Reconstructive Surgery?

Revision surgery is the most common ultimate result of all adverse events associated with hip replacements. It is usually required due to severe pain and malfunction of the joint as tissue is damaged and no longer able to function appropriately. It will require the removal of the malfunctioning device, reconstruction as needed, and the implantation of a new device. Recovery is often much longer than the original surgery.

In many severe side effect cases caused by DePuy Pinnacle Hip Replacement System, ASR XL Acetabular System, or ASR Hip Resurfacing System implants, patients must undergo revision surgery. Some patients may also require reconstructive surgery.

Revision and reconstructive surgeries are often much more invasive and painful than the original joint replacement surgery. Patients are required to undergo longer rehabilitation periods and are exposed to additional surgical and recovery risks including infection, inflammation, pain, and immobility. Some patients have to undergo multiple surgeries to repair damage caused by DePuy implants.

What Year Were These DePuy Systems Used?

Not all DePuy hip replacement systems have caused serious complications in patients. Only those implanted within certain years may be cause for concern.

When Was the DePuy Pinnacle Used?

The DePuy Pinnacle system was approved by the FDA in 2000, and it was taken off the market in 2013. Hip replacements done during this time frame using the metal-on-metal version of the Pinnacle system may cause serious complications.

When Were the DePuy ASR Systems Used?

Any hip replacement surgeries prior to July 2003 will not have used the DePuy ASR System. Hip replacement surgeries performed after July 2003 may have used the DePuy ASR System. The hospital and/or surgeon that performed the hip replacement should have a record of what brand was used.

Have There Been Any Lawsuits Against DePuy?

Thousands of lawsuits have been filed against DePuy in both state and federal courts.

DePuy faces thousands of federal lawsuits regarding the Pinnacle devices. These lawsuits have been consolidated in the U.S. District Court for the Northern District of Texas, and additional lawsuits exist in other areas such as Florida.

Over 90,000 patients worldwide received a DePuy ASR implant and nearly 40 percent of those devices may be expected to fail. The first lawsuit regarding DePuy ASR implants was settled in 2013 for more than $8.3 million. Johnson & Johnson, the parent company of DePuy agreed to settle more than 8,000 federal lawsuits in Ohio for $2.5 billion. Additional lawsuits are consolidated in New Jersey, Indiana, and California and in other state and local courts. The manufacturer may be expected to pay at least another $1.5 billion for ASR implant lawsuits.

As of 2019, at least 46 states filed suit against Johnson & Johnson. A multistate settlement of $120 billion was reached.


  1. (as required by 21 CFR 807.92 and 21 CFR 2 – Food and Drug Administration. (n.d.). Retrieved July 29, 2022, from
  2. AG Paxton announces $120 million settlement with Johnson & Johnson for falsely marketing hip replacement devices. Texas Attorney General. (n.d.). Retrieved July 29, 2022, from
  3. Center for Devices and Radiological Health. (2019, March 15). Concerns about metal-on-metal hip implants. U.S. Food and Drug Administration. Retrieved July 29, 2022, from
  4. DePuy. (n.d.). DePuy ASR Articular Surface Replacement. Articular Surface Replacement. Retrieved from
  5. DePuy. (n.d.). Pinnacle Acetabular Cup System Design Rationale. Retrieved July 29, 2022, from
  6. Information for hip replacement patients who have DEPUY … – (n.d.). Retrieved July 29, 2022, from
  7. Johnson & Johnson. (2012, June 14). Johnson & Johnson Announces Completion of Synthes Acquisition. Retrieved July 29, 2022, from
  8. Johnson&Johnson. (n.d.). Johnson & Johnson acquires DePuy, 1998. Johnson & Johnson Acquires DePuy | Johnson & Johnson Our Story. Retrieved July 29, 2022, from
  9. Johnson&Johnson. (n.d.). Pinnacle® Acetabular Cup system | depuy synthes. PINNACLE® Acetabular Cup System. Retrieved July 29, 2022, from

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