Wright Medical Hip Replacements: Failures, Recalls & Safety Concerns

Wright Medical produced several metal-on-metal (MoM) hip implant components before eliminating the last of its hip implant business in 2016. Even after that, Wright Medical faced hip replacement lawsuits and other controversies surrounding its Conserve, Profemur and Dynasty MoM hip implant lines.

The Dangers of Wright Medical’s Metal-on-Metal Design

Metal-on-metal (MoM) hip implants, including those made by Wright Medical, raised serious health and safety concerns due to wear and corrosion issues.

Unlike other types of hip implants, MoM devices have metal parts that move against each other. This friction can cause tiny metal ions to enter the body. These particles could lead to tissue damage, bone loss and a type of metal poisoning called metallosis.

Over time, these issues can cause pain, loosen implants and make the devices fail sooner than expected, often requiring another surgery to fix them.

These issues made MoM hips unsafe for many patients. Because doctors couldn’t predict who would react badly to the metal particles — and hip replacement complications were often severe — they largely stopped using MoM hip implants to protect patient health.

A 2016 study in The Open Orthopaedics Journal discovered high revision rates for Wright Medical’s Conserve metal-on-metal (MoM) hip implants. The research raised concerns about the device’s safety.

Researchers reviewed 108 hip implants in 92 patients and discovered that nearly 1 in 5 Wright hip implants required revision surgery within 4.5 years.

Due to these risks, the hospitals in the study stopped using Wright Medical’s Conserve MoM hip, contributing to the broader phaseout of MoM hip replacements.

Wright Medical’s hip implants — like the Conserve, Dynasty and Profemur — have faced safety and legal issues. Many patients suffered serious complications, leading to lawsuits and increased scrutiny from regulators.

While some implant devices received full FDA approval, others got clearance through the quicker “premarket submission” process called 510(k). This fast-track approach raised questions about their long-term safety. Medical devices approved through the 510(k) premarket submission route must show they are “substantially equivalent“ to a device already on the market.

Wright Medical Conserve System

The Conserve Plus Total Resurfacing Hip System received the FDA’s full premarket approval (PMA) in 2009. This approval indicated that it met strict safety and effectiveness standards.

Wright Medical Dynasty Total Hip Systems

A version of the Dynasty hip implant that combines metal parts with ceramic and plastic components is still available today. However, there were plenty of issues with the original metal-on-metal version.

Lawsuits claimed that Wright Medical advertised the Dynasty Total Hip Device for “young, very active patients” because it provided “a greater range of motion” without “wear-related concerns.” However, these implants had “dangerously high revision rates in women” and the potential for metallosis and other issues, according to court documents.

In addition, Wright recalled 900 Dynasty Biofoam Shells in 2012 due to issues with improper packaging, causing surgeons to “unintentionally implant” debris from packaging components into patients. These issues occasionally required revision surgery to remove particulate debris.

Wright Medical Profemur System

Clinical studies have linked Wright’s Profemur hip implants to catastrophic failures. A 2015 study in the journal Clinical Orthopaedics and Related Research found the Profemur Z model had a 6% neck fracture rate within five years, while the Profemur E had a 9% loosening rate.

These regulatory issues and complications contributed to Wright Medical’s extensive litigation and eventual financial settlements.

FDA Effectively Banned Metal-on-Metal Hips

In 2016, the FDA effectively ended the 510(k) fast-track approval method for MoM hips, though it still exists for some other medical devices. The FDA decided that all metal-on-metal total hip implants now needed special permission before gaining market approval. Companies had to show they were safe and worked correctly before advertising them.

Since no company was able to get this approval, metal-on-metal hip implants essentially vanished from the market in the United States. Today, there are only two FDA-approved options for MoM hip resurfacing procedures and no FDA-approved MoM hip replacement devices.

Wright Medical faced multiple lawsuits over its metal-on-metal hip implants, including the Conserve, Dynasty and Profemur systems. The legal actions focused on claims that Wright poorly designed and manufactured the devices, causing painful injuries and significant medical costs. As a result, Wright Medical faced mounting litigation in both federal and state courts, ultimately leading to substantial settlements.

A federal panel combined four Wright Conserve hip lawsuits into a multidistrict litigation (MDL) in 2012. MDLs combine several similar lawsuits into a single litigation to speed up the legal process. Eventually, there were 640 cases in this litigation (MDL-2329).

A California Judicial Council Coordination Proceeding (JCCP) combined additional cases involving Conserve, Dynasty and Lineage implants that required revision surgery.

In 2016 and again in 2017, Wright Medical offered a pair of settlements to resolve its MoM hip cases in the MDL and JCCP.

These settlements compensated affected patients while closing ongoing litigation against Wright Medical. However, the lawsuits also highlighted the broader risks associated with metal-on-metal hip implants, prompting increased scrutiny of similar devices.

Wright Medical sold its hip and knee division to MicroPort Scientific in 2013 for $290 million. Wright merged with Tornier in 2015, acquiring another line of hip implant products. However, it divested its newly acquired large joint division in 2016, selling the line to Cornin Orthopaedics for $33 million.

If you had hip replacement surgery before May 18, 2016, you might have a Wright Medical or other brand of metal-on-metal implant. Your doctor can confirm. Regular check-ups are important to catch potential issues early and avoid complications.

Steps to Take With a Wright Medical Metal-on-Metal Hip Implant

Monitoring symptoms and keeping up with regular doctor visits can help detect problems early, reducing the risk of serious health issues. If you experience pain or other unusual symptoms, seek medical advice right away.

If symptoms worsen, contact your surgeon immediately to prevent further problems.

Resources for Metal-on-Metal Hip Implant Patients

Staying informed is key to managing your health with a metal-on-metal implant. Trusted organizations like the FDA and medical research centers provide up-to-date information on risks, safety recommendations and treatment options. These sources can help you make informed decisions about your care.

If you have concerns about your implant, don’t wait for symptoms to worsen. Talk to your doctor about testing options and possible next steps. By being proactive, you can protect your health and help ensure the best possible outcome for your hip implant.