Consumers Union has called on medical device companies such as Zimmer and Stryker to provide warranties that would cover the cost of replacing defective knee implants directly to those surgeons who perform replacement surgeries. As of February 2014, the policy and advocacy division of Consumer Reports asked that, "Medical device makers should be willing to provide a warranty that spells out how long they will stand by their products and a process for getting it replaced at no cost if the implant turns out to be defective."
About 1.2 million hip and knee surgeries are performed in the US each year and as baby boomers age, up to 4 million implants per year are predicted. Most knee implants are supposed to last from 15-20 years but the failure rate is estimated at 10 percent and often because the knee implant is defective, according to the American Association of Orthopedic Surgeons. Eight percent of knee replacements lead to costly and painful revision surgery.
Consumers Union urged medical device manufacturers, including Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc, and Zimmer Holdings to provide a warranty to include the following:
- Covers the full cost of replacing the flawed device, including the device, surgeon and hospital costs as well as related patient out-of-pocket costs.
- Establishes a clear system for patients to use, including a toll-free phone line and a registration number to track the claims process, with physicians charging the device company, not the patient.
- Does not eliminate the patients right to sue if they use a warranty.
- Provides the patient with a full explanation if a warranty claim is denied and an appeals process for denials.
- Does not disqualify patients across the board if they have specific diseases or illnesses that are not related to the failure of the device.
Zimmer, maker of the NexGen knee implant, markets the NexGen CR-Flex Fixed Bearing knee in both a cemented and uncemented version (that is, a version that uses an adhesive to connect the thigh bone and the devise and a version that allows the bone and devise to bond via natural bone growth). In both cases, the artificial knee was expected to last patients for at least 15 years, but some surgeons point to an allegedly higher-than-normal rate of failure for the uncemented CR-Flex Porous Femoral component.
Issues with the Zimmer NexGen CR-Flex Porous Femoral component allegedly include loosening of the implant and failure of the knee implant, which could require revision surgery for repair.
Symptoms of loosening of the knee implant include pain and limited mobility in the affected joint. Patients who believe they are having problems with their knee replacement are advised to have a bone scan (rather than an x-ray, which will not show loosening of the knee implant).
Lawsuits have been filed against Zimmer regarding various NexGen Knee implants alleging the NexGen high-flex knee implants are defective and associated with unnecessary injury to patients. As of September, 2013 there are 1,035 cases pending in the Zimmer NexGen knee implant Multidistrict Litigation (MDL 2272, US District Court for the Northern District of Illinois).
In August 2013 a lawsuit filed in Texas Eastern District Court (case no. 5:2013cv00095) claims the Zimmer NexGen knee implant is defective due to loosening. The plaintiff had to undergo revision surgery. A Nevada resident suffered the same complications, underwent revision surgery and filed a defective knee lawsuit (case no. 2:2013cv01975, Nevada District Court).
The Stryker ShapeMatch Cutting Guide is used during total knee replacement surgery to put the replacement components in place and guide the surgeon when marking the bone before the bone is cut. The Stryker ShapeMatch Cutting Guides are single-use devices used with the Triathlon Knee System. They were designed to allow for smaller incisions in the knee and to customize the surgery for each patient's anatomy.
Stryker ShapeMatch Cutting Guide
The Stryker cutting guides involve the use of an MRI prior to surgery so that a three-dimensional model of the knee can be made. The 3D model is used to determine the size and position of the knee implant. Once those are determined, the ShapeMatch technology is used to create a customized guide to aid the surgeon in making incisions and implanting the knee.
There are concerns, however, that the device can be misaligned, causing knee implants to be placed in the wrong position, resulting in joint instability, pain, limited mobility and fractures. The US Food and Drug Administration (FDA) noted when it announced a Class I Urgent Medical Device Recall of the Stryker ShapeMatch that it had received 44 reports of incidents linked to the ShapeMatch.
Zimmer "Gender Solutions" Natural Knee Flex System, Prolong Articular Surface, knee implants were recalled in 2009 due to difficulty inserting the polyethylene into the tibial baseplate. This issue could result in "intraoperative damage to the device," according to the FDA.
Zimmer Natural Knee Implant
In August 2003, the manufacturer of the Oxinium Pro-Fix II and the Oxinium Genesis II recalled the knee replacement products due to issues with the devices bonding properly. This failure reportedly resulted in infection, joint damage and muscle damage.
Smith & Nephew Knee Implants
In March, 2010 the FDA recalled Journey II Uni Tibial Baseplates after Smith & Nephew received complaints about baseplates breaking, which requires revision surgery. The Class II recall affected approximately 40,000 Journey II knee implants.
In January 2014 the Australian Governments Department of Health issued a safety alert, advising consumers and health professionals that Smith & Nephew has issued a hazard alert regarding the femoral implant component of the Journey Bi-Cruciate Stabilised (BCS) knee replacement system. This particular knee replacement system has been recalled by the Australian Therapeutic Goods Administration (TGA).
A federal judge in June 2014 ruled that an Ohio plaintiff could proceed with a DePuy Orthopaedics lawsuit. The woman alleged that defects in the DePuy bone cement product led to a premature revision of her knee replacement. The judge further ruled that the woman can seek punitive damages against DePuy due to a plausible lack of compliance with the manufacturing and labeling requirements for the FDA-approved device.
DePuy Knee Implants
Symptoms of a defective knee implant include pain in the knee, swelling at or near the knee joint, decreased mobility and a change in ability to walk. Some knee implant failures might require revision surgery, in which the replacement device is itself replaced. Revision surgery often comes at great cost and with longer recovery times than the initial surgery because the joints must be resurfaced.
Symptoms of Defective Knee Implant
Lawsuits have been filed against the makers of various knee implant products alleging patients were harmed by devices that were defectively designed, in some cases requiring painful and costly revision surgery. If you have had a revision surgery to replace a knee implant device, you may be eligible to file a lawsuit.
Defective Knee Implant Lawsuits
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