Knee Replacement Recalls
The number of knee replacement procedures has grown dramatically in past decades due to improving technology, lower costs and an aging population which desires to stay active later in life. Newer designs have been intended to be longer lasting and more durable for younger patients, but many people end up with faulty knee replacement devices which require revision surgery.
With hundreds of models of knee replacement joint devices having been produced, certain devices have proven more troublesome and resulted in knee replacement recalls.
Knee Replacement Recall Process
In the case of most knee replacement recalls which have been issued, products were voluntarily recalled or recalled in compliance with FDA concerns. Knee products have been recalled due to high numbers of adverse events or known problems emerged in patients who had received the devices.
In some cases, the FDA may be forced to issue a mandatory recall if a manufacturer has not complied with agency requests or concerns. In recent years, all recalls of knee replacement products issued by companies such as DePuy, Zimmer-Biomet, and Stryker, have been joint announcements by the manufacturer and FDA.
Knee Replacement Recalls
About 600,000 knee replacement procedures are performed every year in the U.S. and while most of these are successful, thousands of people experience severe side effects and early device failure. Many of these failures are due to devices that prove to be defective or made using faulty designs and require recall.
An increasing number of people are having knee replacement surgery to restore function to worn or injured joints. The number of knee arthroplasty surgeries has grown due to improving technology, lower costs and an aging population which desires to stay active later in life. Newer designs have been intended to be longer lasting and more durable for younger patients but many people end up with faulty joint replacement devices which require revision surgery.
With hundreds of models of knee replacement joint devices having been produced, certain devices have proven more troublesome and resulted in knee replacement recalls.
Notable recalled knee replacement devices include:
Manufacturer | Knee Implant |
DePuy Orthopedics | Attune Knee Replacement System P.F.C. Knee System Limb Preservation System (LPS) Sigma HP PFJ |
Smith & Nephew | Journey I BCS Knee System |
Stryker Corp | Triathlon Knee System ShapeMatch Cutting Guide |
Zimmer Biomet | Persona Trabicular Metal Tibial Plate NexGen Knee Implants Natural-Knee II Durasul Patella |
Knee Replacement Recall Process and Causes
Medical devices like knee replacement products can generally be recalled in three different ways. A manufacturer may voluntarily recall a product when evidence is showing that it may be harmful to patients. The U.S. Food and Drug Administration (FDA) may request that a manufacturer issue a recall based on adverse event reports and in more severe cases, or in cases where a manufacturer has not cooperated with a request, the FDA may issue a mandatory recall.
If a recall has not been issued as requested, the FDA may take further legal action and may seize defective products as needed. In most cases, manufacturers will issue a voluntary recall or comply with a joint requested recall.
In the case of most knee replacement recalls which have been issued, products were voluntarily recalled or recalled in compliance with FDA concerns. Knee products have been recalled due to high numbers of adverse events or known problems emerged in patients who had received the devices.
Common causes of knee replacement recalls include:
- Device loosening
- Infection
- Persistent and/or severe pain
- Swelling
- Damage to the bone, muscle, and nerves near the device
In many cases, patients who experience serious complications, severe side effects or device failure must undergo knee replacement revision surgery. These surgeries are performed to fix or replace a faulty or broken device. In most cases, a revision surgery will be more complex and require a longer recovery period than the original surgery. In addition, some patients may be required to undergo additional surgeries to reconstruct damaged joint tissue or repair bones that have fractured due to device failure.
Knee Replacement Recall Lawsuits
Many of the recalled knee replacement devices have resulted in thousands of knee replacement lawsuits being filed against manufacturers. All of the large orthopedics device companies have faced thousands of lawsuits for injuries caused by their devices. Some of these lawsuits have been settled but others remain in court systems and more may be expected.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.