Metal on Metal Hip failures continue to plague patients

Metal-on-Metal Hip failures continue to plague patients. Metal-on-metal (MoM) hip implants, once marketed as durable and long-lasting solutions to worn-out hips, have been plagued by significant problems, leading to widespread patient suffering, recalls, and numerous lawsuits.

Metal-on-Metal Hips: What’s the Problem?

The key issue lies in their design: a metal ball moving within a metal cup. This friction, normal in daily activities like walking, causes the release of microscopic metal particles, primarily cobalt and chromium, into the surrounding tissues and bloodstream, leading to Metal-on-Metal Hip failures.

These metal particles can lead to a range of severe complications, often collectively referred to as Adverse Reactions to Metal Debris (ARMD) or Adverse Local Tissue Reactions (ALTR). These reactions can include:

• Metallosis: A buildup of metal debris in the soft tissue around the implant, leading to inflammation, tissue damage, and potentially the destruction of bone and muscle. This can cause severe pain, swelling, and loss of mobility.
• Pseudotumors: Non-cancerous, fluid-filled or semi-liquid masses that can develop around the joint as a reaction to the metal particles. While often asymptomatic, they can cause pain, clicking sounds, and even nerve compression.
• Elevated Metal Ion Levels (Metal Poisoning): The metal ions predominately cobalt and chromium can enter the bloodstream and travel throughout the body, potentially causing systemic health issues such as:
  • Neurological problems (e.g., vision and hearing loss, cognitive impairment)
  • Cardiovascular issues (e.g., heart damage, heart failure)
  • Kidney problems
  • Thyroid dysfunction

• Implant Loosening and Metal-on-Metal Hip failures: The tissue damage and bone loss caused by the metal debris can lead to the implant becoming loose, resulting in pain, instability, and ultimately requiring painful and often more complex revision surgery.
• Osteolysis: Destruction of bone tissue around the implant, further contributing to loosening and increased risk of fractures.

The most common outcome for patients experiencing these complications is the need for a revision surgery to remove the faulty metal-on-metal implant and replace it with a different type of hip prosthesis. Revision surgeries are generally more complex, carry higher risks, and involve longer recovery times than the initial implantation.

Here’s a breakdown of some of the individual metal-on-metal hips and the problems associated with specific manufacturers:

DePuy (Johnson & Johnson)

DePuy, a subsidiary of Johnson & Johnson, faced immense scrutiny for its metal-on-metal hip implants, particularly the ASR XL Acetabular System and the Pinnacle Ultamet hip.

• DePuy ASR XL Acetabular System: This implant was notoriously problematic, leading to a global recall in 2010 due to unacceptably Metal-on-Metal Hip failures rates. The design allowed for significant metal-on-metal wear, leading to metallosis, pseudotumors, and severe tissue damage. Thousands of lawsuits were filed, the lawsuits were consolidated into multidistrict litigation (MDL) resulting in multi-million dollar settlements.
• DePuy Pinnacle Ultamet: While not subject to a full recall like the ASR, the metal-on-metal version of the Pinnacle hip also led to numerous lawsuits. Patients reported similar issues of metal debris release, metallosis, and the need for revision surgeries. Thousands of lawsuits were filed, the lawsuits were consolidated into multidistrict litigation (MDL) resulting in multi-million dollar settlements.

Biomet (now Zimmer Biomet)

Biomet’s M2a-Magnum and M2a-38 metal-on-metal hip implants were associated with significant complications.

• Biomet M2a Magnum: This device also suffered from high wear rates, releasing cobalt and chromium particles, leading to Metal-on-Metal Hip failures. Patients experienced metallosis, adverse local tissue reactions (ALVAL), pseudotumors, and systemic metal poisoning symptoms, including heart damage and vision/hearing loss. No direct recall was issued for the M2a Magnum. Thousands of lawsuits were filed, the lawsuits were consolidated into multidistrict litigation (MDL) resulting in multi-million dollar settlements.

Zimmer (now Zimmer Biomet)

Zimmer faced issues with its metal-on-metal offerings, most notably the Durom Cup and the M/L Taper Hip Implant. Thousands of lawsuits were filed, the lawsuits were consolidated into multidistrict litigation (MDL) resulting in multi-million dollar settlements.

• Zimmer Durom Cup: This metal-on-metal acetabular cup was recalled in 2008 in the U.S. due to a high rate of loosening and early failure. The primary issue was the cup’s inability to properly bond with the bone, often attributed to design flaws and insufficient surgeon training. Patients experienced pain, loosening, and the need for revision surgeries.
• Zimmer M/L Taper Hip Implant: This implant was also linked to problems like corrosion and fretting at the neck-stem junction, releasing metal particles and causing tissue reactions and elevated metal levels in the blood. Lawsuits alleged design, testing, and warning failures.

Smith & Nephew

Smith & Nephew’s metal-on-metal hip implants, including the R3 Acetabular System and certain modular femoral hip systems, also faced significant safety concerns. Thousands of lawsuits were filed, the lawsuits were consolidated into multidistrict litigation (MDL) resulting in multi-million dollar settlements.

• Smith & Nephew R3 Acetabular System: The metal-on-metal R3 liner, designed to facilitate movement, instead led to increased friction and the release of metal shards. This resulted in high Metal-on-Metal Hip failures rates, severe pain, metallosis, bone and tissue deterioration, and even systemic issues. A recall for the R3 Acetabular System was issued in 2012.
• Modular SMF and Modular REDAPT Revision Femoral Hip Systems: These systems were recalled in 2016 due to issues with their modular necks, which led to increased complaints of pain and swelling, indicative of metal wear and corrosion.

The Smith & Nephew Birmingham Hip Resurfacing (BHR) System was a prominent metal-on-metal hip implant that, like many of its kind, eventually faced significant problems and extensive litigation.

Designed as an alternative to total hip replacement, especially for younger, more active patients, it involved capping the femoral head with a metal covering that articulated within a metal acetabular cup. The hope was to preserve more bone and provide a longer-lasting solution. However, the inherent flaws of metal-on-metal technology ultimately led to its downfall.

Problems with the Smith & Nephew BHR System

The core problem with the BHR system stemmed from its metal-on-metal design. As the cobalt-chromium alloy components rubbed against each other during normal movement, they released microscopic metal particles into the surrounding joint fluid and bloodstream. This metal debris caused a range of severe complications, as outlined above.

• Higher Failure Rates, particularly in certain patient groups: Data from joint registries in countries like Australia and England and Wales showed alarmingly high revision rates for the BHR system, especially in women and patients with smaller femoral head sizes. These rates were significantly higher than initially claimed and exceeded acceptable benchmarks for hip implants.

Smith and Nephew Recalls and Hazard Alerts

Smith & Nephew initially issued label changes and hazard alerts regarding the BHR system, particularly in 2010 to warn about risks for female patients and those with smaller femoral heads.

In June 2015, Smith & Nephew officially recalled certain sizes and components of the BHR system from the U.S. market due to higher-than-expected revision rates. This was a significant step, acknowledging the widespread issues. Prior to this, in 2012, the company had also recalled the metal-on-metal R3 Acetabular System liner, which had similar problems with metal debris and high failure rates.

Smith and Nephew BHR Litigation

Key aspects of the litigation include:

• Federal District Litigation (MDL): In April 2017, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated federal lawsuits against Smith & Nephew concerning the BHR system into an MDL, In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation (MDL No. 2775), in the U.S. District Court for the District of Maryland.Thousands of lawsuits were filed, the lawsuits were consolidated into multidistrict litigation (MDL) resulting in multi-million dollar settlements.

Expansion of MDL: The MDL has also expanded to include other Smith & Nephew hip implants, specifically a “Total Hip Arthroplasty (THA) track,” covering devices that combined BHR and non-BHR components but led to similar complications. This further emphasizes the systemic nature of the problems with Smith & Nephew’s metal-on-metal offerings.

Exactech

Exactech faced issues with its Connexion GXL liner, a polyethylene liner, was used in conjunction with metal components, leading to problems. While not strictly a metal-on-metal hip in the same way as some others, the degradation of the liner could still interact with metal components.

• Exactech Connexion GXL Liner (used in MCS, Novation, Acumatch systems): This liner was recalled due to premature wear and deterioration. While the liner itself is plastic, its failure can lead to bone-on-bone rubbing or the release of polyethylene debris, which is toxic to tissue and can also interact with metal components, leading to osteolysis, implant loosening, and the need for revision surgery.

Exactech, a prominent manufacturer of orthopedic implants, including hip, knee, and ankle replacement systems, filed for Chapter 11 bankruptcy on October 29, 2024, in the United States Bankruptcy Court for the District of Delaware. This move was a direct response to the immense financial pressure from widespread product recalls and thousands of product liability lawsuits.

Exactech Bankruptcy

Exactech’s troubles began with a series of recalls, primarily in 2021 and 2022, affecting a vast number of its joint replacement devices. The core issue wasn’t the metal-on-metal design (as with some other manufacturers discussed previously), but rather defective packaging.

• Defective Packaging: Exactech discovered that many of its polyethylene components (plastic liners used in hip, knee, and ankle implants) were packaged in bags that lacked one of the crucial oxygen barrier layers. This packaging defect allowed oxygen to permeate the bag, causing the polyethylene material to prematurely oxidize and degrade before implantation.
• Premature Degradation and Failure: Once implanted, the oxidized polyethylene became brittle and susceptible to accelerated wear, loosening, and failure. This led to a range of severe complications for patients, as outlined above.
• Widespread Exactech Recalls: The initial recall in June 2021 for hip components (specifically the Connexion GXL liner used in Acumatch, MCS, and Novation hip systems) was later expanded to include hundreds of thousands of knee, ankle, and even some shoulder implants manufactured between 2004 and 2021.
• Mounting Litigation: The recalls triggered a flood of product liability lawsuits against Exactech. Patients alleged that the company manufactured defective products, failed to adequately test them, and failed to warn patients and medical professionals about the known risks. By the time of the bankruptcy filing, Exactech faced approximately 2,600 product liability claims.

The Bankruptcy Filing and its Impact on Exactech Hip Litigation

Exactech’s Chapter 11 bankruptcy filing was a strategic decision to manage these escalating legal and financial challenges. Here’s how it impacted the ongoing hip litigation (and other Exactech device litigation):

1. Automatic Stay: Upon filing for Chapter 11, an “automatic stay” went into effect. This legally mandated halt temporarily pauses all pre-existing lawsuits and collection efforts against Exactech outside of the bankruptcy court.
2. This means that individual lawsuits, including those in the federal Multidistrict Litigation (MDL) for Exactech devices (MDL No. 3044, In re Exactech Polyethylene Orthopedic Products Liability Litigation, in the U.S. District Court for the Eastern District of New York), and any state court cases, were stopped.
3. Centralized Claims Process: The bankruptcy court takes over the management of all claims against the company. Plaintiffs with product liability claims (i.e., those who were injured by Exactech’s defective hip implants) become unsecured creditors in the bankruptcy proceedings. They will need to file a “proof of claim” within a specific deadline (known as a “bar date”) to assert their right to potential compensation.
4. Restructuring and Asset Sale: Exactech’s bankruptcy plan involves restructuring its operations and selling substantially all of its assets to a group of existing investors. This arrangement is often referred to as a “stalking horse” bid, meaning these investors have made an initial offer, but the sale is subject to higher and better bids through an auction process. The goal is to keep the company operational while resolving its financial obligations, including those to victims of its defective products.
5. Impact on Compensation:
   • Uncertainty and Delays: The bankruptcy process introduces significant uncertainty and potential delays for plaintiffs seeking compensation. Instead of pursuing individual trials or settlements in civil court, claims are now part of a larger bankruptcy proceeding.
   • Limited Payouts: While bankruptcy doesn’t mean plaintiffs receive no compensation, the amount available for all creditors, including injured patients, is often limited by the company’s assets and insurance coverage. Plaintiffs may receive less than they might have in a successful civil trial. The bankruptcy court prioritizes various types of creditors, and product liability claimants are typically unsecured creditors, meaning they are lower on the priority list than secured creditors.
   • “Trust” Creation: Often in mass tort bankruptcies, a trust is established to compensate claimants. The funds for this trust would come from Exactech’s assets, insurance policies, and potentially contributions from the new owners.
6. Bellwether Trials Halted: The bellwether trials, which were scheduled in the Exactech MDL to help gauge the value of cases, were also paused due to the bankruptcy filing. Their future status will depend on the bankruptcy court’s decisions.

Stryker

Stryker’s metal-on-metal hip implants, notably the Rejuvenate and ABG II Modular-Neck Stem Systems and certain LFIT V40 femoral heads, were subject to recalls and numerous lawsuits. Thousands of lawsuits were filed, the lawsuits were consolidated into multidistrict litigation (MDL) resulting in multi-million dollar settlements.

• Stryker Rejuvenate and ABG II Modular-Neck Stem Systems: These were recalled in 2012 due to concerns about fretting and corrosion at the modular neck junction. This design flaw led to the release of metallic ions and particles, causing severe local tissue reactions (ALTR), metallosis, bone death (necrosis), and intense pain, necessitating revision surgeries.
• Stryker LFIT V40 Femoral Heads (certain sizes/lots): These cobalt-chromium femoral heads, when used with titanium alloy stems, could lead to galvanic corrosion and accelerated wear. This problem resulted in recalls in 2016 and 2018 due to higher-than-expected complication rates, including taper lock failure and the release of metal particles.

Wright Medical

Wright Medical’s metal-on-metal hip implants, particularly the Conserve and Profemur systems, were linked to Metal-on-Metal Hip failures rates and patient injuries. Thousands of lawsuits were filed, the lawsuits were consolidated into multidistrict litigation (MDL) resulting in multi-million dollar settlements.

• Wright Conserve Plus: This all-metal hip implant, consisting of a cobalt-chromium femoral head and acetabular cup, was heavily marketed to younger, active patients with claims of long-lasting performance. However, studies revealed unacceptably high revision rates due to the release of toxic metal wear debris, leading to metallosis, necrotic tissue, fluid buildup, and severe pain.
• Wright Profemur System: Certain Profemur models were associated with catastrophic failures, including a high rate of neck fractures (Profemur Z) and loosening (Profemur E) within a few years of implantation. Exposure to metal debris also caused tissue reactions and elevated metal ion levels, often requiring revision surgery.

Conclusion Metal-on-Metal Hip Debacle

In summary, the promise of durability and reduced wear that initially fueled the popularity of metal-on-metal hip implants largely failed to materialize. Instead, the design flaw of metal-on-metal articulation led to widespread complications stemming from metal debris, causing both localized tissue damage and systemic metal toxicity. The repercussions have been significant for both patients, who endured pain, disability, and multiple surgeries, and the manufacturing companies, which faced extensive litigation, recalls, and a decline in the use of these devices.

Failed Metal-on-Metal Hip Implant? Injured by Metal-on-Metal Hip Implant? Contact Dr. Shezad Malik Law Firm.

If you or a loved one had a Metal on Metal Hip Implant and have suffered Hip Implant fracture injuries or needed premature revision surgery with the device, contact the attorneys at Dr. Shezad Malik Law Firm to learn more about your legal rights.

You can speak with one of our representatives by calling 214-390-3189, or by filling out the case evaluation form on this page.

Our law firm’s principal office is in Dallas, Texas. Dr. Shezad Malik Law Firm represents clients in dangerous drug and dangerous medical device lawsuits nationwide.

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