Most patients believe that their hip replacement has completed a satisfactory amount of clinical trials before being used in surgical procedures. The DePuy Pinnacle® Hip Implant System was permitted to reach the market under the U.S. Food and Drug Administration’s (FDA) controversial 510(k), approval process, which allows a medical device to be placed on the market without being subjected to necessary clinical trials as long as the manufacturer asserts that the device is “substantially equivalent” to a device already approved on the market.
The DePuy Pinnacle® Acetabular Cup System was approved in 2002 as a larger diameter metal-on-metal hip replacement system.
The Pinnacle system uses a metal insert, creating a metal-on-metal application utilizing a metal ball and metal lined cup to replicate the natural movement of a hip joint.
This is in contrast to the typical hip replacement system that uses a synthetic plastic liner inside a socket component of the synthetic joint.
Recently, the FDA has received hundreds of complaints and adverse incident reports against the Pinnacle system, attributed mostly to the Pinnacle’s propensity to prematurely separate from the bone. Moreover, like many other metal-on-metal devices, constant friction in the Pinnacle may cause an increased risk of metalosis, i.e. the release of miniscule metal particles into the surrounding soft tissue or bloodstream.
DePuy, a subsidiary of Johnson & Johnson, has sold more than 150,000 DePuy Pinnacle® Hip Implant devices, outselling the recalled DePuy ASR™ hip implant device. The company faces thousands of legal claims filed by hip implant patients across the U.S. as its hip implants have been associated with a high failure rate.
To date, more than 1,300 “adverse event reports” have been filed with the FDA regarding the Pinnacle hip implant. A recent report by the British Hip Society states that many metal-on-metal hip implants fail early, some with a failure rate of almost 50% at six years. The DePuy Pinnacle® utilizes a metal-on-metal design, which experts have identified as a distinct flaw that can cause metal particles (wear debris) to collect inside a patient’s body, resulting in metal toxicity and other related problems.
WHAT YOU SHOULD KNOW
Much of the problem seems to be with the Pinnacle Ultamet Metal-on-Metal component which is failing at an unacceptably high rate. One of the theories seeking to determine the cause suggests that a design problem flows from the fact that the device has been created with one of the lowest clearance levels in the industry. The only other implant with a clearance level this low is the DePuy ASR., which has been recalled.
Patients should be aware of the health risks, which include pain, premature loosening or detachment, and metal toxicity. You may have a claim against Johnson & Johnson and DePuy. The law firm of Pope, McGlamry, Kilpatrick, Morrison & Norwood, P.C. has assembled a team of lawyers that have extensive experience defending clients who have suffered after misplacing their trust in negligent companies that produce harmful products.
If you or someone you know have a DePuy Pinnacle hip replacement system and have suffered pain or any other issues:
- See your doctor immediately.
- Do not release any of your confidential medical information to any DePuy representatives before speaking to an experienced hip replacement counsel.
- If you are told that you will need hip revisions surgery, make sure that the removed component parts are preserved. Your counsel should be familiar with this process and working with the proper experts to insure that it is done correctly.
Disclaimer: All useof the Pinnacle mark is for informational and product identification purposes only. This post should not be taken as either medical or legal advice, but instead should act as a resource in providing general information that may be useful to the general public. Pope, McGlamry, Kilpatrick, Morrison & Norwood, P.C. is not affiliated with the medical device manufacturers, DePuy Orthopaedics, Johnson & Johnson, or their distributors.