Defective Knee Implants
Allegedly defective knee implants have been a cause of concern for medical professionals and patients alike, with some knee implant devices being the subject of recalls due to a high rate of complications, ranging from infection and trauma to loosening or poor implant positioning, along with a defective medical device. Among issues allegedly associated with knee implant failure are debonding of the joints, pain in and around the knee, decreased mobility and range and other problems often leading to revision surgery. Many defective knee implant lawsuits involve metal-on-metal devices.
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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 patient' 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.
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).
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 Natural Knee Implant
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 Government' 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).
DePuy Knee Implants
Symptoms of Defective Knee Implant
Defective Knee Implant Lawsuits
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