Zimmer VerSys Hip Implant Recalled

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Zimmer VerSys Hip Implant Recalled

Zimmer VerSys Hip Implant Recalled

In Medical Device Recall, Zimmer: In the NewsPosted

Zimmer VerSys Hip Implant System Recalled Due to Early Failure Rates

What should I watch out for?

The hip joint is an important ball and socket joint in the body that helps a person rotate their hips and walk.  It is common for people to need hip replacement surgery due to injury, disease or advanced age. Approximately 500 million people a year receive artificial hip implants. 

There are many different types of hip implant devices available for people requiring hip replacement surgery. Unfortunately, the hip implant devices are commonly defective and do not work correctly once they have been implanted. This may cause patients to have multiple surgeries to fix the problems, or may lead to many dangerous side effects, including death.

The U.S. Food and Drug Administration (“FDA”) has investigated several hip implant manufacturers throughout the years. Recently, the Zimmer VerSys hip replacement system was recalled because of its link to serious side effects, including early failure rates of the implant and metal blood poisoning, known as metallosis.

What side effects do Metal-on-Metal hip implants cause?

Hip replacement systems have a stem, ball and cup that the ball rests in. These components are made of different types of materials, including metal, ceramic and plastic. The Zimmer VerSys artificial hip system has a metal cup and femoral stem. Similar to metal-on-metal hip implants on the market, serious side effects can include:

  • Early failure of the hip replacement device
  • Bone fractures
  • Damage to the tissues
  • Differences in the lengths of the legs
  • Infections
  • Loosening of the device
  • Loud noises from the device, including grinding, popping or clicking
  • Metal blood poisoning (metallosis)
  • Movement of the device, leading to device dislocation
  • Pain, including hip pain and pain when walking or standing
  • Death

Who makes VerSys Hip Implants?

Manufacturer Zimmer introduced the VerSys hip implant system. The VerSys hip system was approved and cleared for marketing through the FDA’s 510(k) Premarket Notification Process. Under the process, a drug or medical device company only needs to show that their product is substantially similar to a product that has already received FDA approval. Zimmer’s VerSys hip system was approved because it was similar to other already sanctioned technologies.

The Zimmer hip system has three components:  the acetabular cup, the ball (which replaces the femoral head) and the stem (which fits into the femur).

The Zimmer VerSys stem is matched to different Zimmer heads. Friction due to normal movement of the metal cup and femoral stem can cause cobalt and chromium particles, known as ions, to shed.

Besides causing metallosis, or metal poisoning, the Zimmer VerSys hip design is more likely to produce wear and debris under fretting conditions. Fretting refers to wear and sometimes corrosion damage where the metal components of the VerSys hip design connect. Studies have noticed a worrisome number of premature failures due to metal corrosion at the head-neck taper junction on the VerSys hip.

Comparable to the VerSys system, Zimmer’s M/L Taper with Kinectiv Technology was removed from the market in April 2015. In June 2015, the FDA issued an urgent class I recall for Zimmer’s M/L Taper with Kinectiv Technology. The FDA’s recall letter announced that Zimmer found a higher than expected amount of manufacturing residue on the products. The residue can cause “serious adverse health issues including allergic reactions, pain, infections or death. Use of these products may require the need for a revision surgery to replace the affected implant,” according to the company.

In 2006, Zimmer also manufactured the Zimmer Durom Cup hip replacement system. By 2008, Zimmer temporarily suspended sales of its Durom Cup device after a world-renowned hip surgeon warned Zimmer of the extremely high revision surgery rate among Durom Cup patients. Zimmer temporarily placed the Durom Cup implant back on the market for a while, but ultimately discontinued sales of the Durom Cup in 2010.

Which hip implants are metal-on-metal devices?

Metal-on-metal hip implants are marketed to younger individuals with an active lifestyle who want to improve their quality of life and continue an on-the-go lifestyle.  These metal-on-metal hip devices are supposed to be more durable than other hip implant devices, such as ceramic-on-ceramic models or metal-on-plastic models.  Instead, the metal-on-metal hip implants are failing at alarmingly high rate.

Some well-known metal-on-metal hip device systems include:

What other artificial hip devices have been recalled?

Several hip replacement recalls have been made on popular hip systems in recent years, including:

Most of the recalls were voluntarily recalled by the hip device manufacturer instead of being recalled by the FDA. Device manufacturers are obligated to accurately design, produce, test, and market their products. Manufacturers also have a duty to inform the public of potentially damaging complications and device failures.

These hip systems were recalled for many reasons, including:

  • Design flaws
  • Early failure of the hip implant
  • Fractured implants
  • Labeling issues
  • Manufacturing issues
  • Packaging issues
  • Design flaws
  • Movement of the device
  • Missing components

Numerous metal-on-metal hip replacement lawsuits have been filed in recent years as the number of patients with complications from metal-on-metal devices have risen. Hip replacement manufacturers are starting to reach settlements to resolve lawsuits alleging dangerous side effects caused by the defective metal-on-metal hip devices. The lawsuits allege the manufacturers knew about the hip implant risks and failed to warn doctors or the public about the known risks.

Be on Watch

If you or a loved one had a hip device implanted since 2000 and experienced complications, you may qualify for financial compensation for medical expenses, medical treatment, loss of income, and injuries suffered.


Call us at (888) 458-6825 or send us an email inquiry to discuss your legal options. 

The consultation is free and confidential.

 

Resources:

  1. FDA concerns about Metal-on-Metal Hip Implants https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm
  2. Reuters metal allergies article June 20, 2014 https://www.reuters.com/article/us-joint-replacements-metals-allergy-idUSKBN0EV1TY20140620
  3. The New York Times hip implant failure article January 22, 2013 https://www.nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-in-thousands-more.html?_r=0
  4. Class 2 Device Recall Zimmer VerSys August 2006 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=47847