Defective Knee Replacement Lawsuit

Over the years, surgical procedures and medical devices have continued to evolve. Unfortunately, complications with surgical implant procedures are still occurring. Thousands of people who had DePuy Synthes Attune Knee Replacement Systems and Exactech Optetrak and Optetrak Logic Knee Implants surgically implanted have experienced device loosening and other critical failures. Many of these patients are filing lawsuits and blaming the manufacturer for producing and marketing a defective knee implant.

If you suffered injuries due to a defective knee implant, you may qualify to file a lawsuit against the defective medical device’s manufacturer. To find an experienced lawyer who can help you file a lawsuit, contact The Guardian Legal Network.

When is Knee Replacement Needed?

More than 600,000 knee replacements take place in the United States every year. The surgical procedure is usually the final resort after other forms of treatment no longer help control the pain. The American Academy of Orthopaedic Surgeons lists the most common sources of pain that cause the need for knee replacements:

Rheumatoid arthritis – Inflammation erodes cartilage in the joints and can eventually cause cartilage loss.
Osteoarthritis – Cartilage becomes thin and wears away as patients get older, then bone rubs against bone, creating tremendous pain.
Post-traumatic arthritis – A joint that suffered any type of physical injury becomes worn out.

During knee replacement surgery, the first step is to have the cartilage removed. Next, metal components are implanted on the joint’s surface. Plastic material is typically used to resurface the kneecap. Then, to give the materials an easier surface to glide on, a spacer is placed between the metal components

The DePuy Attune System

Several components make up the knee replacement implant called the DePuy Attune System. These parts are:

Glideright Articulation – This portion handles the interaction taking place between the kneecap and femur.
Attune Gradius Curve – By working with the tibia and femur, this portion minimizes unnatural sliding.
Logidock Tibial Base – Essential for stability, this section attaches to the tibia and is available in differing sizes for matching the femoral size.
Sofcam Contact – This component stabilizes the knee during walking.
AOX Polyethylene Insert – The material used for this spacer is said to provide excellent wear resistance and offer long-term stability.

Exactech Recall

Two recalls have recently been issued by the orthopedic device company Exactech, Inc. for their Exactech Optetrak and Optetrak Logic knee implants.

In February 2022, a recall was issued for the Exactech Optetrak and Optetrak Logic knee implants when it was discovered that the polyethylene liners used were showing premature wear which could lead to accelerated excessive device wear, bone loss, and overall device failure.

A second recall was issued in February 2022 for Exactech knee replacements, as a review of the manufacturing process identified that from 2004 until 2022, one of the packaging layers used in the production of knee replacements was not up to proper specification. This allowed oxygen from the air to enter the plastic insert before being implanted. Additional oxygen can lead to oxidation, causing the plastic to wear out earlier than expected and deteriorate after implementation.

Both of these issues can cause damage to the device and patient and result in the need for additional corrective surgery. Those affected should reach out to a doctor to see if revision surgery is necessary and to an attorney to see if they qualify for legal assistance.

Complications from Knee Replacement Surgeries

A growing number of recipients are experiencing complications after knee replacement surgery. Lawsuits are being filed claiming the following complications:

Chronic pain and swelling still occurring months after surgery
Loosening or fracturing of the implanted device
Stiffness and instability that creates difficulty walking
Bone weakening around the implant (osteolysis)
Premature wear, breakage, or fracture of the polyethylene portions
Deficient wound healing
Periprosthetic infection requiring additional surgery
Bleeding
Lessened range of motion
Blood clots
Blood vessel or nerve damage
Fracturing of bones during surgery

Patients who experience a failed device or other complications after knee replacement surgery may be eligible to receive financial compensation.

Lawsuits Surrounding Faulty Knee Replacements

Because of the severity of complications experienced by many patients who have undergone knee replacement surgery, a large number of lawsuits have been filed against device manufacturers. Plaintiffs are alleging that the device makers did not properly design, create, or market their implant devices. Many victims claim the manufacturer failed to ensure that the replacement devices were safe and that they would perform exactly as the maker claims.

In order to correct malfunctions that occurred during or after the original replacement surgery, numerous follow-up replacement procedures have been required, causing extensive and painful recoveries for patients each time. Hundreds of affected individuals allege in their lawsuits that the devices have not worked as promised. More than 600 cases have been brought against Zimmer, the manufacturer of NexGen. The suits seek compensation for medical costs, rehabilitation, lost wages, home health care expenses, pain and suffering, and permanent or temporary disability.

So far, lawsuits number in the thousands against Smith & Nephew, DePuy (part of Johnson & Johnson), Stryker, Zimmer Biomet, Exactech, and Wright Medical. The biggest portion of the remaining outstanding cases are against Zimmer Biomet and have been consolidated for convenience in the United States District Court for the Northern District of Illinois.

Lawsuits Surrounding Defective Knee Implants

Many lawsuits have been filed by patients who have undergone knee replacement surgery and suffered severe side effects. Patients have had to undergo revision surgeries to correct complications caused by a defective knee implant. These surgeries cause extensive and painful recoveries for patients.

Victims claim that the device manufacturers did not properly design, produce, or market their knee implant devices. Many victims claim the manufacturer failed to conduct adequate tests to see if the knee implants were safe. Thousands of cases have been brought against manufacturers over defective knee implants. The lawsuits seek compensation for medical costs, rehabilitation, lost wages, home health care expenses, pain and suffering, and permanent or temporary disability.

The defective knee implant manufacturers include:

Zimmer Biomet – NexGen CR-Flex and Vanguard CR
Johnson & Johnson – DePuy Synthes Attune Knee System
Stryker – Triathlon Total Knee System, Scorpio CR, and PS components
Smith & Nephew – Journey BCS, Oxinium Genesis ll, Profix ll, and Journey Uni Tibial
Exactech – Optetrak and Optetrak Logic

Reports of Knee Implant Loosening and Failure

Researchers examined FDA reports on the Manufacturer and User Facility Device Experience (MAUDE) database related to DePuy Synthes Attune devices. Hundreds of reports involving the Attune system were found.

After looking through the evidence, the researchers said they had “encountered a high rate of debonding of the tibial implant–cement interface.” In an examination of three hospital databases, researchers found 15 cases of tibial loosening in the Attune system. They also found 21 reports of tibial loosening in the MAUDE database just two months before the study concluded.

History of Knee Replacement Recalls

In both 2007 and 2008, DePuy was ordered to recall their P.F.C. knee systems. The recall was issued due to a defect in the knee replacement joint that would cause the artificial joints to wear out and eventually break quickly.

In 2009, the P.F.C. Sigma knee system was forced to recall due to a femoral component that could cause severe side effects to patients.

In 2014, DePuy issued three recalls for three different knee replacement devices. The first recall was issued for the 100 S-ROM Noiles hinges due to packaging defects and safety concerns related to sterility. Later in 2014, DePuy’s Attune Intuition knee system issued two recalls for one component that had a high risk of cracking and another component that could fracture and leave parts of the device in a patient.

In 2015, thousands of DePuy’s Attune knee systems had to be pulled off the market due to a surgical tool that was reportedly breaking and leaving pieces inside patients’ surgical sites. There was a wire spring coil in the Attune Knee Tibial Articulation Surface Instruments that was prone to damage. Doctors were unaware that this component was breaking, and thousands of patients were at risk of complications. The Class II Device Recall dealt with more than 3,000 units.

In 2017, DePuy was forced to recall their Sigma HP PFJ cemented trochlear implant. This component caused a high rate of knee replacement revision surgery. Patients have reported that these defective parts may become dislocated and misaligned.

In February 2022, Exactech issued two recalls over knee replacements, one dealing with the polyethylene liners showed premature and excessive wear and a second.

Find a Defective Knee Implant Lawyer Today

Those who have been forced to undergo revision surgery after being implanted with a defective knee implant should seek a medical device lawyer. A skilled lawyer will help you determine whether a lawsuit is the best path forward.

Contact The Guardian Legal Network to find an experienced defective knee implant lawyer who will fight to get you the compensation you deserve.

Fill out an online contact form or give us a call at (855) 968-0184 today.

References

Eric Peters. “Patient-surgeon consensus needed in determining candidates for knee replacement surgery”, https://www.news.vcu.edu/article/Patientsurgeon_consensus_needed_in_determining_candidates_for. Accessed January 26, 2021.
Depuy Synthes. “ATTUNE® Knee System”, Johnson & Johnson, https://www.depuysynthes.com/hcp/knee/products/qs/ATTUNE-Knee-System. Accessed January 26, 2021.
FDA. “Class 2 Device Recall ATTUNE” Articulation Surface”, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137734. Accessed January 26, 2021.
FDA. “MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE BAL SIZER DISTRACTOR KNEE INSTRUMENT/TRIAL”, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4259356. Accessed January 26, 2021.
FDA. “Medical Device Recalls”, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=&centerclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=03%2F02%2F2014&productshortreasontxt=&firmlegalnam=DePuy&knumber=&pnumber=&PAGENUM=500. Accessed January 26, 2021.
FDA. “Medical Device Recalls”, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=&centerclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&productshortreasontxt=&firmlegalnam=DePuy&knumber=&pnumber=&PAGENUM=500. Accessed January 26, 2021.
FDA. “Summary of Safety and Effectiveness Attune Total Knee DePuy Orthopaedlics”, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/cdrh_docs/pdf10/K101433.pdf. Accessed January 26, 2021.
Jared R. H. Foran, MD. “Total Knee Replacement”, OrthoInfo, https://orthoinfo.aaos.org/en/treatment/total-knee-replacement/. Accessed January 26, 2021.

Please seek the advice of a medical professional before making health care decisions. The content provided on this site, such as documents, text, graphics, images, videos, or other materials, are for informational purposes only. The information is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always consult a physician for diagnosis and treatment of any medical condition or for any questions you may have regarding a health concern. Never disregard professional medical advice or delay in seeking it because of something you have read or seen on this site.