Consumer Reports Says Lemon Law Should Cover Hip & Knee Replacement Failure

Nearly 20% of all hip replacements and 10% of knee replacements done each year are secondary revision surgeries to replace defective devices, according to Consumer Reports.

Knee and hip replacement complications such as infection, bone loss, device loosening, dislocation and longer hospital stays are more common than with the initial procedures. The price tag is also much higher– a cost that is passed onto consumers and insurers like Medicare, adds the consumer advocacy group.

The Consumers Union is fighting to have defective device replacement covered by the manufacturers, rather than the patients, to encourage companies to make safer and more durable products.

“While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty,” explained Lisa McGiffert, director of Consumers Union’s Safe Patient Project.

Hip replacement complications

Since 2003, roughly 750,000 Americans received metal-on-metal hip implants. According to ten years of data collected by Consumer Union, the metal-on-metal hip implants caused the greatest number of complications, compared to ceramic and plastic implants. Metal hip implants were more likely to fail and patients were also more likely to suffer from heart damage or neurological problems when the metal flaked off the device and traveled elsewhere in the body.

The biggest manufacturers of these metal hip replacement systems include:

• DePuy Orthopedics (Johnson & Johnson)
• Stryker Orthopedics
• Zimmer
• Biomet
• Wright Medical
• Smith & Nephew

So far, hip replacement complications have led to recalls of the DePuy ASR XL Acetabular hip; the Stryker Rejuvenate, ABG II and Trident hips; and the Smith & Nephew R3 Acetabular hip.

Knee replacement failure

Consumer Union reports that knee replacement failure is less common than hip replacement failure, but hundreds of components have been recalled since 2003. Often, the devices were sent out with the wrong parts, wrong part sizes, missing components or improperly etched pieces.

Manufacturers of defective knee replacement systems include:

• DePuy Orthopedics (Johnson & Johnson)
• Stryker Orthopedics
• Zimmer
• Biomet
• Wright Medical
• Smith & Nephew

Recalls have been issued for the DePuy LCS Knee Implant-Meniscal device, PFC Sigma Knee System, and the LPS Diaphyseal Sleeve; Smith & Nephew Oxinium Genesis II, Oxinium Profix II, and Journey Uni Tibial Baseplate; and the Zimmer NexGen Complete Knee Solutions Minimally Invasive Surgery Tibial Components, Locking Screw, Stem Extensions, LPS Flex Gender Femoral Component and LPS Femoral Component.

Hip and knee lawsuits

Unfortunately, unlike a “lemon” used car or virtually any other consumer product, there are no warranties or guarantees offered by sellers of dangerous medical devices. In fact, most manufacturers are able to skip ordinary FDA approvals by gaining market clearance through a 510(k) process, which states that they can bypass safety reviews if they are “substantially equivalent” to products currently being sold.

The Safe Patient Project recommends that Biomet, DePuy, Smith & Nephew, Stryker, Zimmer Holdings and Wright Medical Technology offer a 20-year warranty that covers the full cost of revision surgery, replacement devices, hospital stays and patient out-of-pocket expenses. Patients should also be given a clear system with a toll-free hotline and registration number that enables them to track their claims process. For now, the patients’ only recourse is to sue the manufacturers in a knee or hip replacement lawsuit in hopes of recouping some of the expense for hip and knee replacement failure.