Recovery after knee surgery

Zimmer Knee Implants

Zimmer, a manufacturing and marketing firm for thousands of products that include many orthopedic implant and instrumentation systems, has issued recalls for several of its knee implant devices. These products are now the subject of Zimmer knee lawsuits filed by people who required additional surgeries to address complications like pain in the joint, overall loosening and premature failure of the device.

Complications from Zimmer Knee Replacement Devices

  • Loosening or fracture of the device components
  • Joint instability and dislocation
  • Component misalignment and breakdown
  • Nerve damage
  • Bone fracture
  • Swelling and joint pain
  • Severe knee pain
  • Poor range of motion
  • Device failure

There have been four Zimmer knee replacement product recalls of Zimmer Knee components due to reports of adverse complications:

  • Zimmer NexGen Complete Knee Solution MIS Tibial Components, NexGen TM Tibial Trays and MIS Modular Tibial Plates and Keels
  • Zimmer NexGen LPS-Flex Gender Femoral Component
  • Zimmer Natural-Knee II Durasul All-Poly Patella
  • Zimmer Persona Trabecular Metal Tibial Plate

Problems with MIS Tibial Components

Zimmer designed the NexGen MIS Tibial component for use with two other NexGen Flex Knee products, the LPS-Flex and CR-Flex. The MIS Tibial component is used in minimally invasive surgical procedures where surgeons operate through a 4- to 5-inch incision as opposed to an 8- to 12-inch incision used in traditional surgery. This technique aims to reduce blood loss and lessen recovery time after surgery, but it is also more challenging and leaves considerable room for error. The product is supposed to lead to a greater range of motion for patients because it allows tissue-sparing techniques where doctors can assemble the components in place through the smaller incision. However the faulty pieces tend to make the procedure even more problematic.

After reports of high failure rates with the MIS Tibial Component, Zimmer issued an “Urgent Field Safety Notice”/“Urgent Device Correction” letter in April 2010, leading to FDA recall in September of the same year. Zimmer admitted that part of the problem with the MIS Tibial Component design is that “MIS procedures are inherently challenging and can involve reduced visibility, which may lead to difficulty achieving proper implant alignment and cement fixation.”

In May 2014 Zimmer issued another recall for the MIS Tibial Component, a Class 2 recall indicating the damaged device might cause temporary or serious medical complications. Medical professionals received an Urgent Medical Device Recall letter from Zimmer stating that the threads on the NexGen Complete Knee Solution Tibial Component might be “out of specification” in more than 40,000 devices. Some of the tibial baseplates were made with defective threads in a hole where surgeons screw in a drop-down stem extension or stem plug. If not threaded correctly, the device could loosen and fail.

The voluntary recall affects 41,180 devices and includes eight sizes (1-8).

Problems with NexGen LPS-Flex GSF Femoral Component

& Natural-Knee II Durasul All-Poly Patella

The NexGen LPS-Flex GSF Femoral Component is also part of the series of Zimmer NexGen knee recalls. This device is marketed for use in female patients, and claims to provide a superior fit and increased stability. One of the biggest problems with this component is its tendency to loosen and “collapse,” requiring further revision surgery. It was recalled by the FDA in December 2010 due to “nonconforming geometry” that caused the implant parts to fail due to improper fit.

One of the least publicized recalls was in January 2012 involving the Natural-Knee II Durasul All-Poly Patella. This product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture. It was also prescribed for patients with previous failed surgeries resulting in persistent pain, deformity, or dysfunction persists. The FDA issued a Class 2 recall in tandem with Zimmer, citing the product was prone to fracture causing device failure and patellar problems. At the time of the recall, more than 100,000 devices had already been implanted.

Problems with Persona Trabecular Metal Tibial Plate

Zimmer initiated a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are currently being removed from distribution. Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on February 16, 2015. All affected product are to be located and quarantined immediately.

The Persona Trabecular Metal Tibial Plate is a part of the Zimmer Persona Knee system that is used without cement to provide proper fixation to the bone – a design much like that of  a natural knee. The implant can be used with a wide variety of components and utilized by surgeons in a number of surgical styles.

Zimmer reported it received an increased number of complaints about component loosening and radiolucent lines. Radiolucent lines are gaps between the component and the bone or between the components themselves. They typically happen when a knee implant part is not secured correctly. These gaps can fill with joint fluid, tissue or debris from implant wear, causing osteolysis bone damage that lead to loosening and ultimate implant failure.

 

Our experienced attorneys are ready to help you if you have lasting medical issues involving Zimmer knee implants. We have several offices throughout New York State and Vermont to better serve you, including: Albany, NY, Schenectady, NY, Saratoga, NY, New York City, NY, Plattsburgh, NY, Utica, NY, Buffalo, NY, White Plains, NY, Rochester, NY – as well as Manchester, VT and Burlington, VT. Our lawyers are available day and night to help you if you’ve suffered any medical conditions or complications from a Zimmer Knee implant or device.

Call Today

If you or someone you know received a knee implant involving one of the Zimmer Knee devices listed above, you may be eligible for financial compensation. In addition, if you received a Zimmer knee recall letter, it is important to act.

Call us today at 1800LAW1010 (1.800.529.1010) to determine your eligibility and find out what legal action you may take regarding these defective products. We’re here to help.