Sunday, April 27, 2014

What are the Issues With the Ultamet Metal-on-Metal Pinnacle Liner?

Although DePuy’s ASR hip implant device was recalled in August, 2010, the company has continued to sell its Pinnacle model, even though the DePuy Pinnacle hip implant and the ASR have many design features in common. The Pinnacle has been in production since FDA approval in 2000, with over 150,000 of the devices sold and implanted between that time and today—despite the fact that while the Pinnacle was designed to last at least 15 years, orthopedic surgeons are reporting failures within 1-2 years. While the DePuy Pinnacle and the ASR are similar, there are also specific differences between the two, including:

                                                            

·         The Pinnacle has an outer shell, while the ASR cup is a solid piece of metal

·         The Pinnacle allows surgeons the option to place a metal, ceramic or polyethylene liner inside the metal outer cup

 

The goal—according to DePuy—of offering the variety of liners was to allow surgeons more freedom in choosing a bearing surface for the individual patient, based on body type, age, and level of activity. It appears that the primary issue with the DePuy Pinnacle hip implant is associated with use of the Ultamet metal liner. When the metal liner is used, the result is friction and corrosion between the cup and ball-shaped head. This friction leads to the generation of excess metal ion debris; these microscopic cobalt and chromium ions can enter the bloodstream or the surrounding hip tissue. When the ions burrow into the hip tissues, inflammation, pain and loss of mobility can result, as well as destruction of the bone and tissue. The implant can fail completely, requiring hip revision surgery. Metal ions which enter the bloodstream can lead to chromium and cobalt poisoning, with such adverse health symptoms as:

 

·         Gastrointestinal disorders

·         Skin rashes

·         Vertigo

·         Depression, anxiety, irritability

·         Cardiovascular issues

·         Loss of hearing and vision

·         The development of certain types of cancers

·         Pseudo-tumor development

·         Disruption of DNA

·         Renal failure

·         Hypothyroidism

·         Neurological disorders

·         Short-term memory loss

 

Despite the more than 1,300 adverse event reports submitted to the FDA regarding the DePuy Pinnacle hip implant—and specifically the Ultamet metal-on-metal Pinnacle liner—as well as the more than 4,000 federal and state lawsuits currently filed against DePuy and Johnson & Johnson, the companies continue to maintain the Pinnacle implant is safe, with no design defects. Lawsuits against DePuy and Johnson & Johnson dispute this claim, alleging defects were deliberately concealed and misrepresentations were made to consumers regarding the safety and effectiveness of the Pinnacle, when used with the Ultamet metal liner. 

Design Flaw Theories of the DePuy Pinnacle Hip Implant

One of the theories regarding the design issues associated with the Ultamet metal-on-metal Pinnacle liner is that the device has one of the lowest clearance levels in the industry—the only other implant with a clearance level this low is the recalled DePuy ASR. Experts believe there is a very narrow margin for proper placement of the Pinnacle hip implant with the Ultamet liner. Many of the complaints received from the FDA regarding the DePuy Pinnacle hip implant center around the Pinnacle’s propensity to prematurely separate from the bone, in addition to the DePuy Pinnacle metallosis and Pinnacle chromium and cobalt poisoning.

 

Although there has been no recall of the DePuy Pinnacle hip implant, if you feel you have been harmed by the Pinnacle—particularly when coupled with the Ultamet metal-on-metal Pinnacle liner—you should see your physician and have blood tests done to measure your levels of cobalt and chromium. After seeing to your health, it could be in your best interests to speak to a DePuy Pinnacle hip lawyer regarding a potential DePuy Pinnacle lawsuit.     

Print
0 Comments
Please login or register to post comments.

WARNING: Do not send any information in any email through this website if you consider the information confidential or privileged.

I understand that by submitting my contact information to Sullo & Sullo LLP for review, I consent to messages regarding this legal matter as well as marketing for other potential legal matters in the future without limitation at standard messaging and data rates unless terminated by me in writing. I further understand that my submission of any and all information in response to this website does NOT create a lawyer-client relationship between myself and Sullo & Sullo, LLP and/or its lawyers, and that any and all information submitted is NOT confidential or privileged. I further acknowledge that, unless Sullo & Sullo, LLP subsequently enters into an Attorney-Client relationship with me, any and all information I provide will NOT be treated as confidential or privileged, and any such information may be used against me and/or for the benefit of current or future clients of Sullo & Sullo, LLP. ...READ ENTIRE DISCLAIMER
Receive an Immediate Response
ANDREW SULLO IS A TOP 100 NATIONAL TRIAL LAWYER 2013 • 2014 • 2015 • 2016 • 2017 • 2018 • 2019
Obtener una Respuesta Inmediata
Andrew Sullo – 100 Mejores Abogados Nacional | 2013 • 2014 • 2015 • 2016 • 2017


4.6/5.0

STARS ON YELP
WITH OVER 400 REVIEWS*

*AS OF 2024



Andrew Sullo has been named a

TOP 100 NATIONAL TRIAL LAWYER*
2013-2024

*BY THE NATIONAL TRIAL LAWYERS

 

CALL NOW FOR A FREE LEGAL CONSULTATION
(800) 730-7607
CALL NOW FOR A FREE LEGAL CONSULTATION (713) 839-9026 CALL NOW FOR A FREE LEGAL CONSULTATION (713) 335-9485


Andrew Sullo is a recipient of the

AVVO CLIENT'S CHOICE AWARD*
2016, 2017, 2019-2024

*GIVEN BY AVVO


Justice

Andrew Sullo is a Member of the

AMERICAN ASSOCIATION OF JUSTICE
2013-2024

*GRANTED BY THE AAJ

 

IF YOU OR A LOVED ONE WERE SERIOUSLY INJURED DUE TO THE NEGLIGENCE OF ANOTHER, CONTACT SULLO & SULLO IMMEDIATELY.
CALL NOW
(800) 730-7607
CALL NOW
(713) 839-9026
CALL NOW
(713) 335-9485

GET LEGAL HELP