Metal-On-Metal Hip Replacements Cause Zimmer Lawsuits to Erupt

In August of 2010, Johnson & Johnson subsidiary DePuy recalled both its ASR and ASR XL hip replacements systems after growing pressure from the FDA over the devices' unusually high failure rate. And doctors in the United Kingdom have reported that DuPuy products have a failure rate as high as 49% after only six years. The reports of problems with various metal-on-metal designs has become so troubling that on May 6, 2011, the Food and Drug Administration ordered a study of 145 different metal-on-metal hip replacements designs made by 21 different manufacturers. As the metal ball-and-joint scrape against each other, tiny particles of metal debris wear off within the patient. The particles can float freely within the joint, embed into nearby tissue or even enter the bloodstream, causing havoc on the patient's body.

The Durom Cup was first sold in the U.S. by Zimmer, in 2006, and it was implanted in more than 12,000 Zimmer hip replacement patients over the two-year period from the Summer of 2006 to the suspension of sales in July 2008. Based on information received from discussions with hip surgeons throughout the country, estimates on the failure rate of the Zimmer Durom Cup hip replacement range between 20% and 30%. The true failure rate of the Zimmer Durom Cup may climb much higher in the coming years as doctors and their patients come to realize that their implants are gradually failing.

Zimmer Durom Cup Issues Are Wide and Far Reaching

The Zimmer products, sold under the brand name Durom, are marketed as a set of ball-and-socket components for use in hip resurfacing, or as a metal socket for use with other components in a conventional hip replacement, have been the subject of many a Zimmer Hip Lawyer. Researchers, whose study was underwritten by Zimmer, urged in their report that the Durom components no longer be used in standard implants because of “these excessively high metal ion levels.” In this country, the Durom product is used only in conventional implants; the resurfacing system is not approved for sale. A temporary Zimmer Durom Cup recall was issued in July 2008, so that revisions could be made to the product’s warnings and instructions to ensure that doctors were properly trained on the surgical techniques needed to implant the artificial hip correctly.

Over 12,000 people in the United States have had a Zimmer Durom Cup implanted during their hip replacement surgery. While Zimmer’s own estimates in 2008 suggested that some doctors experienced Zimmer hip failure rates as high as 5.7%, some claims have suggested that the between 20% and 30% of people may experience problems with a Zimmer Durom Cup hip. The recent Zimmer Durom Cup issues were first noticed by prominent orthopedic

Are Zimmer Hip Lawsuits Linked to 510(k) Overhaul?

After a slew of Zimmer hip replacement lawsuits regarding the Zimmer Durom Cup, the Food and Drug Administration has requested that a study be conducted on the effectiveness of the current 510(k) medical device approval process that is in place. This process allows devices, such as joint replacement systems like the Durom Cup, that are similar to medical devices already on the market to be approved more quickly because of their similarities to the pre-existing devices.

Based on the number of patients who have had complaints about serious problems and complications associated with their medical devices – many a Zimmer hip lawyer has filed lawsuits against Zimmer and other makers of orthopedic and joint replacement devices after experiencing more severe hip complications, some of which necessitated Zimmer  hip revision surgery – it appears as though this expedited approval process for some medical devices is not appropriate or safe for consumers.

Are Zimmer Hip Lawsuits Linked to 510(k) Overhaul?

After a slew of Zimmer hip replacement lawsuits, the Food and Drug Administration has requested that a study be conducted on the effectiveness of the current 510(k) medical device approval process that is in place. This process allows devices, such as joint replacement systems like the Durom Cup, that are similar to medical devices already on the market to be approved more quickly because of their similarities to the pre-existing devices.

Harris Hip Score Used To Evaluate Zimmer Hip Problems

Patients who have been implanted with a Zimmer hip replacement system have, since 2006, faced hurdles in recovery. The problems include: unexplained hip pain more than three months after hip replacement, loosening of their artificial hip implant and hip replacement revision surgery. Potential lawsuits are being investigated on behalf of individuals who have experienced issues with the Zimmer Durom Cup.  Doctors have reported a number of problems with the artificial hip replacement component, which have resulted in the need for additional surgeries for many patients. When talking with your physician about problems with your hip replacement, they will present you with a series of questions known as the Harris Hip Score. The questions will center around the subjects of: pain, support, distance walked, limp, stairs, sitting, etc.

Although the Harris hip score frequently is used to assess the outcome of total hip replacement, only a few minor validity tests have been presented. The aim of this study was to perform a validity test of the Harris hip score and to test its reliability.  The Harris hip score can be used by a physician or a physiotherapist to study the clinical outcome of hip replacement. Most validity tests show the Harris Hip Score to be a good indicator of a successful hip replacement, but not everyone responds to issues with their hip replacements the same way. Those who are rated between “fair” and “poor” according to their score, may be entitled to and wish to seek damages due to a defective Zimmer hip replacement.

In April 2008, prominent Los Angeles orthopedic surgeon, Dr. Larry Dorr, notified members of the American Association of Hip and Knee Surgeons about the Zimmer Durom Cup problems he was encountering with patients who received the component. In July 2008, the manufacturer decided to suspend U.S. sales of the product, but a Zimmer Durom Cup recall was not issued since they did not uncover evidence of any manufacturing defect or design defect. Over 12,000 people in the United States have had a Zimmer Durom Cup implanted during their hip replacement surgery.  Hundreds of these people could experience loosening of the component and the need for additional surgeries