Zimmer M/L Taper Class 1 Recall

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Zimmer M/L Taper with Kinectiv Technology Class 1 Recall

What should I watch out for?

Hip replacement surgeries are very common types of surgeries, with about 500,000 people every year undergoing the surgery. Unfortunately, many patients who have one hip replacement surgery have to have a second hip replacement surgery, also known as revision surgery. This is also the case for many patients who received the Zimmer M/L Taper implant.

The device manufacturers of the hip implants commonly make faulty hip implants that do not work correctly inside their patients and cause harmful side effects.  These dangerous side effects have led to hip implant device recalls from the U.S. Food and Drug Administration (“FDA”).

One hip implant device that has been recalled by its manufacturer is the Zimmer M/L Taper with Kinectiv Technology. The Zimmer M/L Taper with Kinectiv Technology has femoral stems and modular necks with metal components in the device that have been linked to blood poisoning and many serious side effects.

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

  • Allergic reactions
  • Metallosis, or metal blood poisoning
  • Damage of the tissue from the metal debris
  • Death
  • Differences in the lengths of the legs
  • Dislocation of the device
  • Early device failure rate
  • Fracture of the bone
  • Infections
  • Loosening of the device
  • Noise from the device, including clicking, popping or grinding
  • Pain in the hips
  • Pain when walking, standing or carrying weighted objects

Metallosis, or metal blood poisoning, is a dangerous complication and can cause:

  • Pain
  • Swelling
  • Inflammation
  • Elevated temperatures
  • Headaches
  • Dizziness
  • A gray discoloration around the hip implant area
  • Damage to the central nervous system

If you have experienced any of the above symptoms and have received a metal-on-metal hip implant, please contact your doctor immediately. Do not sign a release to a hip replacement manufacturer representative without speaking with an attorney. If your doctor tells you that you need hip revision surgery, make sure that the removed hip implant parts are preserved and consult your attorney to make sure they are saved properly.

Who makes M/L Taper with Kinectiv Technology?

Manufacturer Zimmer introduced the M/L Taper with Kinectiv Technology on March 31, 2015.  This product was on the market until April 20, 2015.  On June 8, 2015, the FDA issued a class I recall for Zimmer’s M/L Taper with Kinectiv Technology.  A class I recall is the most urgent of FDA recalls, indicating that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

This Zimmer product was designed to “precisely match a wide range of male and female anatomies without compromise” through several types of modular neck components. The Zimmer M/L Taper with Kinectiv Technology used a modular neck system, which is inserted into the femoral stem at a fixed angle. A taper was then used to connect the two components.

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.

On May 18, 2015, Zimmer issued recall notification letters and instructions to hospital staff and distributors of the Zimmer product. Zimmer noted the recall was due to metal femoral stems and modular necks that caused “higher than allowed cytotoxicity levels” found with the product.

Zimmer also manufactured the Zimmer Durom Cup hip replacement device in 2006. Zimmer temporary suspended sales of the Durom Cup device in 2008 after a warning from a well-known hip surgeon cautioned Zimmer of the higher-than-normal revision surgery rate among Durom Cup patients. After briefly putting the Durom Cup implant back on the market, Zimmer ultimately discontinued sales of the Durom Cup in 2010.

Tell me more about the Zimmer M/L Taper with Kinectiv Technology.

During total hip surgery, a prosthetic joint replaces the entire hip structure.  Specifically, an orthopedic surgeon puts the hip stem into the patient’s femur, replaces the femur head with a ball and replaces the socket with an artificial cup.

Kinectiv Technology is marketed as special technology because of the “exclusive use of 0+ femoral heads. This allows independent adjustment of leg length and offset since all adjustments are made with the necks.”  Kinectiv Technology “allows the surgeon to optimize leg length without affecting offset and conversely offset without affecting leg length.”

The Zimmer M/L Taper with Kinectiv Technology has modular stem and neck components.  The individual neck and stem provides several options to customize the artificial device to the patient’s body. The modular necks and stems are Tivanium alloy implants.

Similar to metal-on-metal hip devices, where both the ball and socket components are made of metal, the Zimmer M/L Taper with Kinectiv Technology has metal modular necks and stems, which cause friction when the metal components rub together in everyday movement. This friction causes metal debris to enter the bloodstream, and eventually leads to severe levels of cobalt and chromium in the bloodstream. This metal poisoning, also known as metallosis, can cause inflammation, headaches, dizziness, pain, cobalt poisoning and damage to the central nervous system.

What other manufacturers produce hip replacement devices?

There are several hip device manufacturers that produce artificial hip implants. The most common manufacturers include:

  • Zimmer
  • DePuy
  • Stryker
  • Smith & Nephew
  • Wright
  • Biomet

Have other modular neck designs had problems?

Modular neck designs with other manufacturers have experienced problems.  Besides Zimmer M/L Tape, the modular neck design with a titanium neck on Stryker’s Rejuvenate hip implant had serious complications. In 2012, Stryker recalled the Rejuvenate hip due to its high incidence of fracturing.

Modular neck technology is known to have issues with corrosion where the metal neck snaps on the femoral stem. The metal debris goes into a patient’s bloodstream and causes alarmingly high levels of metal in the patient’s body.

Be on Watch

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

Call us at (800) 684-2136 or send us an email inquiry to discuss your legal options. 

The consultation is free and confidential.

 

Resources:

  1. Zimmer M/L Taper Hip Prosthesis http://www.zimmer.com/content/dam/zimmer-web/documents/en-US/pdf/surgical-techniques/hip/zimmer-ml-taper-hip-prosthesis-surgical-technique.pdf
  2. FDA Zimmer M/L Taper Hip Prosthesis recall https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=137182
  3. FDA concerns about Metal-on-Metal Hip Implants https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm
  4. Reuters metal allergies article June 20, 2014 https://www.reuters.com/article/us-joint-replacements-metals-allergy-idUSKBN0EV1TY20140620
  5. 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