Metal-On-Metal Implant Problems Spark FDA Warning

After receiving more than 5,000 complaints of negative reactions, the FDA began analyzing the safety and potential risks of all-metal hip implants. The complaints have alleged problems with the devices and led sufferers to contact a Zimmer hip lawyer to seek compensation for their injuries. These people have suffered from a range of issues such as heavy metal blood poisoning, inflammation and bone fractures, and dislocation of the implant.

One of the devices cited in these complaints is the Zimmer Durom Cup. A rising number of lawsuits have been filed nationwide due to this device. Patients often required revision surgery to repair and replace the implant and are filing cases to recover compensation.

No recall implemented for Zimmer’s Durom Cup

Zimmer temporarily suspended sales of the Durom Cup in July of 2008, but a Zimmer hip recall was never implemented. Zimmer placed the product back on the market approximately a month later and provided revised instructions to physicians. Other companies in addition to Zimmer have been implicated in metal device complaints. Johnson & Johnson and DePuy also manufacture metal implants. Complaints have been lodged with lawsuits seeking damages from these companies as well.

FDA issues safety communication regarding metal-on-metal implants

A new safety communication was issued by the FDA on January 17, 2013, concerning metal-on-metal implants. The intent was to inform orthopedic surgeons and patients who might receive a metal implant or have already had one surgically implanted of the risks.

These devices have been under examination by the FDA for several years after receiving reports of complications with devices made of cobalt-chromium-molybdenum alloys. These have been connected to early rates of failure, metal grinding, and loosening of the device.

Officials of the agency state that there are unique risks to the metal devices in addition to the general risks of any hip implant. Damage to the bone and/or soft tissue surrounding the implant can occur from metal particles wearing from the device.

FDA identifies patients at higher risk for complications

Metal-on-metal devices consist of a ball, stem and shell. These have been linked with soft tissue damage from the components rubbing against one another during activity. When this happens, metal shards can break off and enter the bloodstream and surrounding tissues. Tissue damage is commonly a precursor to the implant loosening, chronic pain and discomfort, and the need for revision surgery.

The FDA identified patients who might be at higher risk for complications due to these types of devices, including:

• Those taking corticosteroids in high dosages

• Those with metal sensitivity

• Females

• Those that are severely overweight

• Recipients of bilateral implants

• Those with weakened immune systems

• Those with renal (kidney) problems

• Those who have received resurfacing systems with small femoral heads

Doctors encouraged to follow up with metal-on-metal implant patients

The FDA encourages doctors to follow up with patients who have shown symptoms or potential problems such as popping noises, a lack of mobility, and pain or swelling in the area of the implant.

Patients who have received metal-on-metal implants and experience any symptoms that indicate their device could be faulty or not working as it is supposed to should have metal ion testing.