In June of 2015 the FDA recalled the ATTUNE® Knee Replacement System which is made and marketed by DePuy Synthes, a medical device division of Johnson & Johnson. In its warning letter to DuPuy, the FDA stated that parts of the knee replacement system were changed or replaced without FDA approval and that these parts were dangerous and could result in painful, costly and time consuming revision surgery. Worldwide, more than 700,000 total knee replacement surgeries used the Attune device.
Knee replacement devices historically have a lifespan of 12 to 20 years. Premature failures of between one and five years are increasingly being reported when the Attune Knee Replacement System was used.
Nine prominent orthopedic surgeons reported an unusually high rate of premature failures as cited in the June 7, 2017 Journal of Knee Surgery. The surgeons attributed the failures to the “de-bonding” of the device’s tibial implant-cement baseplate to the patient’s bone. In plain English, the surgeons determined that the cement holding the Attune implant in place does not stick adequately to the tibial part of the Attune Knee System. This causes a loosening of the Attune device and destabilization of the entire system.
In cases where Attune Knee Systems have failed, the only solution for the patient is revision surgery. As of June 2017, there have been 1,400 reports of device failure in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Six hundred thirty-three of these reports—a whopping 45% cited revision surgery. The surgeon must remove the Attune knee implant and replace it with a new device in order to prevent permanent damage.
There are design and manufacturing defects in the Attune knee replacement system. Specifically, the cement holding the Attune implant in place does not stick adequately to the tibial part of the Attune Knee System. This causes a loosening of the Attune device and destabilization of the entire system resulting in pain and limited mobility for the patient.
In June 2015 the FDA ordered DePuy Synthes, the medical devices unit of Johnson & Johnson, to issue a worldwide voluntary recall of several of the component parts of its Attune knee replacement system for failing to receive prior FDA approval. The reasons were twofold: The FDA found that the components did not receive prior approval and they were altered and no longer safe.
Knee replacement systems have a lifespan of 15-20 years. Your doctor will be able to ascertain if your knee replacement implant has failed. If your implant failed shortly after surgery and you are in pain, suffering from an inability to walk properly and comfortably, or have already undergone revision surgery, you may be entitled to compensation. Contact a personal injury lawyer for expert advice.
The first lawsuit was filed on September 13, 2017 and has not yet settled. Variables that affect settlement amounts include the amount of money the victim has lost due to the injuries caused by the device, medical expenses incurred, as well as pain and suffering. Your personal injury attorney will be able to provide you with an expected compensation range.
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Medical Device Watch is sponsored by Keefe Law Firm. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.LEARN MORE