Depuy Pinnacle Hip Replacement System
DePuy Orthopaedics Inc., a unit of Johnson & Johnson, manufactures the Pinnacle Hip Replacement Systems which was approved in 2001 by the Food and Drug Administration. Since then, it has been implanted in approximately 150,000 individuals in the United States.
The Depuy Pinnacle hip replacement system is one of several models sold by DePuy and is known as a “metal-on-metal” implant. While hip implants typically last 15 years or more, many doctors reported that Pinnacle implants failed soon after implantation in many patients; often within two years.
Out of the 1,300 complaints received by the U.S. Food and Drug Administration (FDA) regarding the Pinnacle hip replacement, the majority of these focused on the premature loosening of the device from the bone, leading to failure of the device. Many patients will need to undergo corrective surgery within five years after their initial hip replacement surgery.
In response to the DePuy ASR hip recall, a US senate committee convened for a special hearing on the 510(k) premarket approval process on April 13. At the hearing, the committee heard evidence that devices approved through 510(k) are more likely to be recalled than products approved through more stringent regulatory pathways.
Since that meeting, the FDA has taken the unusual step of asking about 20 orthopedic manufacturers to undertake studies on patients implanted with metal-on-metal hip implants.
If you or a loved one has been injured as a result of a recalled Depuy Pinnacle Hip Replacement System, you may be entitled to receive compensation for your pain and suffering. Medical device manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for use. Failure to do so or failure to make consumers aware of any potential problems may be grounds for personal injury litigation.
If you or someone you love received a Depuy Pinnale hip implant, you may qualify for compensation for physical damage, additional surgeries and your pain and suffering, you should contact the Plymale Law Firm for a free consultation by filling out the form on this page or by calling us at (877) 328-7670.