The ConforMIS iTotal G2 Knee Replacement has been linked to complications including chronic pain, bone damage, dislocations, immobility, device failure and the need for revision surgery. Product liability lawsuits allege that design defects made the iTotal G2 unreasonably dangerous with numerous flaws that adversely affect patients’ health.
Free ConforMIS Knee Replacement Lawsuit Evaluation: If you or a loved one suffered an injury after receiving a ConforMIS knee implant, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against ConforMIS, Inc. and we can help.
What is the ConforMIS Knee Implant?
The iTotal CR Knee Replacement System incorporates technology that generates patient-specific knee implants to build a 3D image of a patient’s knee. The image is then used to design a personalized knee implant. ConforMIS Inc. touts these devices as having “unparalleled advantages” because they precisely fit each patient resulting in “extremely low polyethylene contact stress,” preserving more bone than standard knee replacements and giving patients a “long lasting” and “naturally feeling” knee.
In October 2012, the U.S. Food & Drug Administration (FDA) approved the next generation iTotal G2 Knee Replacement System via 510(k), a process that requires little safety data and only some information concerning the products’ efficacy. The iTotal G2 includes an implant that is attached to the base of the femur and a tray is implanted into the head of the tibia. Two polypropylene spacers are locked into the top of the tibia tray on both the medial and lateral aspects.
Lawsuit Filed Against ConforMIS Over Defective Knee Implants
In October 2014, a product liability lawsuit was filed against ConforMIS, Inc., which claimed that iTotal G2 knee replacements were defective and injured plaintiff Mary Jane Martine. According to the complaint, the 65-year-old nurse had two separate knee surgeries with the ConforMIS iTotal G2 knee, one in October 2012 and the other in April 2013. By December 2013, Martine began suffering complications with her right knee including severe pain, popping sounds, and the inability to extend her knee or even stand on it. A doctor later determined that both her right and left knee implants were defective. Martine was left with no option but to undergo bilateral revision surgery, and has suffered excruciating pain, bone loss and additional trauma resulting from her recovery.
“The iTotal G2 was unreasonably dangerous and dangerously defective as designed because it was designed with numerous defects that adversely affect patient health,” the lawsuit said. “As a direct and proximate result of the defective design of the iTotal G2, Plaintiff has suffered serious bodily injury, mental and physical pain and suffering, and has incurred economic loss.”
Knee Replacement Complications
Complications associated with the ConforMIS iTotal G2 knee implant include:
- Chronic knee pain
- Bone damage
- Dislocation of tibia tray/spacer
- Device failure
- Revision surgery
Why Removal Surgery is More Complicated than Initial Surgery
ConforMIS knee removal or “revision” surgery is typically more complex than primary or “initial” surgery because the original implant must be removed, which has likely grown into the patient’s bone. Additionally, once the prosthesis is removed, there is less bone remaining. In some cases, a bone graft may be implanted to support the new prosthesis. Bone grafts add support and encourage new bone growth; however, the procedure requires additional pre-operative planning, specialized tools and greater surgical skill.
ConforMIS Knee Recall
- “iUni” (Unicondylar) Knee System recalled in July 2009 over concerns about microscopic cracks that may require premature revision surgery.
- iTotal CR-Cruciate Retaining Knee Replacement System recalled in August 2012 to update the device’s surgical technique guide.
Can I File a ConforMIS Knee Replacement Lawsuit?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against ConforMIS Inc., the maker of the ConforMIS iTotal G2 Knee Replacement, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.
Most cases involving medical devices allege that a product was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain complications. In the case of the ConforMIS iTotal G2 Knee Implant, our attorneys suspect that patients may be able to take legal action in light of claims that ConforMIS Inc. failed to adequately warn doctors and patients about the risk of manufacturing defects that made the device unreasonably dangerous.
How Can Filing a Lawsuit Help Me?
By filing a lawsuit against the maker of the iTotal G2 Knee Replacement, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your injury, as well as for damages for pain and suffering. Additionally, filing a lawsuit can help hold the device’s manufacturer accountable for releasing an allegedly defective product into the marketplace, and to discourage other companies from engaging in similar conduct.
Do I Have a ConforMIS Knee Replacement Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in ConforMIS Knee Replacement Lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
Free ConforMIS Knee Replacement Lawsuit Evaluation: Again, if you or a loved one suffered an injury after receiving a ConforMIS knee implant, you should contact our law firm immediately. You may be entitled to compensation by filing a ConforMIS Knee Suit and we can help.