DePuy Hip Implant Failures, Health Risks & Corporate Controversies
DePuy’s Pinnacle and ASR metal-on-metal hip implants were once seen as joint replacement breakthroughs. However, serious health risks emerged, like implant failure and metallosis. Thousands of patients filed lawsuits, claiming the devices caused severe injuries and required replacement surgeries.
How DePuy Hip Implants Became a Health Concern
DePuy’s metal-on-metal (MoM) hip implants, including the ASR XL Acetabular System and Pinnacle Ultamet, became a concern when they were linked to catastrophic health risks and systemic toxicity. This led to thousands of DePuy hip lawsuits.
The lawsuits over DePuy and other manufacturers’ MoM hips and research on their injuries forced medical device makers to remove metal-on-metal hips from the United States market in 2016.
The Problem With Metal-on-Metal DePuy Hip Implants
A 2023 study in Arthroplasty Today found that up to 36.4% of people who received the DePuy ASR metal-on-metal hip implants experienced problems. In 2017, a study in The Bone & Joint Journal found a 27.1% ten-year cumulative failure rate in DePuy Pinnacle implants.
Compared to other hip implants, that’s a significantly high percentage of failures. A 2013 Kaiser Permanente study placed the average failure rate for hip implants lower, at around 2.3% for women and 1.9% for men.
Problems like metallosis, adverse reactions to metal debris and adverse local tissue reactions all led to high failure rates for MoM hip implants.
- Adverse Local Tissue Reaction
- Local damage from metal particles around an implant can result in pain and lead to implant loosening or failure. You may require early revision surgery to prevent severe tissue, bone or nerve damage.
- Adverse Reaction to Metal Debris
- This term refers to both local and systemic responses to metal debris, including soft tissue damage and the potential for widespread effects. Symptoms often resemble those of adverse local tissue reactions, including pain, implant loosening and device failure, with a possibility of systemic effects like vision loss, hearing impairment and fatigue.
- Metallosis
- Metallosis is a rare condition caused by the accumulation of metal debris in soft tissues, leading to a chronic inflammatory response. It can result in local and systemic problems.
Thousands of DePuy hip lawsuits claimed corporate negligence led to significant injuries. Due to problems and mounting lawsuits, DePuy recalled its ASR hip in 2010 and discontinued its Pinnacle Ultamet in 2013.
Why Some DePuy Hip Implants Require Early Revision Surgery
DePuy and other MoM hip implant failures typically require revision surgery. These failures include hip replacement complications like adverse local tissue reactions, adverse reactions to metal debris and metallosis. These all increase the chances of bone and tissue damage, causing joint failure and the need for revision surgery.
According to the American Academy of Orthopaedic Surgeons, hip implant revision surgery is necessary if you experience a fracture, infection, loosening, reaction to metal ions or recurring joint dislocation.
If you’ve had a DePuy metal-on-metal hip implant, you should have regular check-ups, get imaging tests done and check your metal levels. These steps help doctors look for potential problems arising from your implant.
Regulatory & Legal Battles Over DePuy Hip Implants
Thousands of lawsuits were filed over injuries blamed on DePuy’s ASR and Pinnacle hip implants. The U.S. Judicial Panel on Multidistrict (JPML) consolidated lawsuits into two multidistrict litigations (MDLs). An MDL seeks to streamline the legal process by combining similar lawsuits and injuries into a single litigation.
- MDL 2197: DePuy ASR Hip Implants
- The JPML consolidated seven DePuy ASR lawsuits into an MDL in December 2010. It eventually included 10,453 cases. As of April 2025, 143 lawsuits were still pending in an Ohio federal court.
- MDL 2244: DePuy Pinnacle Hip Implants
- The JPML consolidated three DePuy Pinnacle lawsuits into an MDL in a Texas federal court on May 23, 2011. A total of 10,581 cases were eventually included in the MDL, though many were dismissed or otherwise resolved before DePuy agreed to a blanket settlement. The judge closed the MDL on December 9, 2024.
What Lawsuits Have Revealed About DePuy Hip Implant Failures
In the wake of the individual lawsuits, 46 state attorneys general launched investigations into how DePuy’s parent company, Johnson & Johnson, marketed Pinnacle and ASR hip implants.
The investigation determined DePuy implants deteriorated faster than advertised. Johnson & Johnson marketed the ASR and Pinnacle implants with three-year survivorship rates of 99.2% and 99.9%. However, the National Joint Registry of England and Wales identified revision rates at 7% and roughly 4.3% for those time spans.
Additionally, the attorneys general reported that patients with defective devices or those who needed revision surgery had symptoms like allergic reactions, pain, metallosis and tissue necrosis.
Outcomes of the DePuy Hip Implant Cases
According to a 2018 quarterly report from Johnson & Johnson, agreements were reached in 2013, 2015 and 2017 to settle over 10,000 complaints from U.S. patients who had to replace their ASR hip implants.
Johnson & Johnson agreed to settle Pinnacle hip lawsuits for $1 billion in 2019. The DePuy hip settlements were reached after Texas juries ordered Johnson & Johnson to pay over $1.5 billion to patients who claimed the company misled them about the risks and durability of their Pinnacle hip implants.
In 2019, Johnson & Johnson also agreed to pay $120 million in a settlement involving 46 states over claims it misled consumers about the durability of its ASR XL and Pinnacle implants. DePuy agreed to improve its marketing practices and monitor hip replacement products by using current scientific information and reviewing customer feedback as part of the settlement.
The Push for Safer Hip Implant Designs
In 2016, the U.S. Food and Drug Administration (FDA) introduced a new rule for manufacturers of metal-on-metal total hip implants. In May 2016, manufacturers could no longer sell these devices without getting FDA approval.
To receive approval, manufacturers need to prove that their products are safe and effective. They must also report specific information to the FDA annually and get permission to change the device, its packaging or production methods.
No MoM total hip implants are currently available in the United States. Only two MoM hip resurfacing devices have received FDA approval since 2016.
How Newer Implant Materials and Designs Reduce Health Risks
Newer hip implant materials last longer, reducing health risks compared to older MoM models. These improvements have led to better patient outcomes by avoiding many concerns associated with MoM implants.
- Ceramic-on-Ceramic Bearings
- These implants are made from ceramic materials that wear down less, giving them a longer life expectancy than other products.
- Highly Cross-Linked Plastics
- These special plastics have been shown to last longer and resist wear better, mainly when used alongside ceramic parts.
- Vitamin E-Enhanced Cross-Linked Polyethylene
- This newer material used in total hip replacement surgeries is designed to wear down less and resist damage from oxidation.
What Should You Do if You Have a DePuy Hip Implant?
If you have a DePuy hip implant, educate yourself about the warning signs of implant failure. This ensures you can seek medical help when needed and avoid serious complications.
Identifying Implant Failure and Seeking Medical Help
Metal-on-metal hip implants like the DePuy Pinnacle and ASR can fail over time. If you have a MoM hip implant, see a doctor if you notice any of these symptoms:
- Clicking or grinding noises coming from your hip
- Difficulty walking or stiffness
- Hip pain, especially while walking
- Inflammation
- Recurring hip dislocations
- Signs of infection
Seek medical attention if your symptoms worsen or if you have concerns. Revision surgery may be necessary.
Reliable Sources for Information on DePuy Hip Implant Safety
If you had hip replacement surgery before May 18, 2016, you may have received a metal-on-metal implant. These implants can have some risks, especially as they age.
The FDA recommends talking to your doctor if you’re unsure what type of implant you have. They can answer your questions and provide you with the safety information you need.
- Arthritis Foundation Metal-on-Metal Hip Implant Risks Page
- This resource from the Arthritis Foundation provides important information about the possible risks linked to metal-on-metal hip implants. It also offers help for patients who are having problems with these types of implants.
- FDA Metal-on-Metal Hip Implants Information Page
- This FDA resource has detailed information regarding metal-on-metal hip implants. It includes possible risks, patient advice and updates on safety communications.
- Massachusetts General Hospital (Mass General)
- The Mass General Center for Metal-on-Metal Hip Evaluation and Treatment addresses issues with metal-on-metal hip implants, ensuring patients receive optimal care.
- MedWatch
- This FDA system allows you to document adverse reactions potentially associated with your metal-on-metal hip implant.
The DePuy ASR implant MDL is active, and lawyers are still accepting cases. If you were injured by an ASR hip implant, you should talk with an experienced medical device attorney about filing a DePuy hip lawsuit.
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