A PINNACLE® Acetabular Cup System Product Information Provided by DePuy Orthopaedics, Inc.

Updates

Judgment Returned in Favour of DePuy in ULTAMET Metal-On-Metal UK Hip Trial

May 21, 2018

Judge Mrs. Justice Andrews who presided over the trial in The Royal Courts of Justice returned a judgment in favour of DePuy on May 21, 2018, concerning allegations of defect under UK Consumer Protection laws.

At DePuy we have no greater responsibility than to the patients who use our products. The ULTAMET® Metal-on-Metal hip device is backed by a strong record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain. We are pleased that the court ruled that ULTAMET met the standard of safety under the Consumer Protection Act and performed as well or better than other prostheses that were on the market at the time ULTAMET was introduced. The judge commented that her impression “taken from the evidence as a whole, was that it was a well-designed product with many positive engineering features.” We hope this decision reassures patients of the safety of the ULTAMET® Metal-on-Metal device.

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Johnson & Johnson and DePuy to Appeal Jury Verdicts in Dallas ULTAMET Metal-on-Metal Hip Trial

November 16, 2017

“We have no greater responsibility than to the patients who use our products. We acted appropriately and responsibly in the development of ULTAMET Metal-on-Metal, and the device is backed by a strong record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain. We will immediately begin the appeal process and remain committed to the long-term defense of the allegations in these lawsuits.” - Stela Meirelles, spokesperson for DePuy

Background Information
The Alicea trial consolidated the cases of six individual plaintiffs from New York. Prior to trial, the Fifth Circuit Court of Appeals determined that the MDL court committed "grave error" in ruling that it had jurisdiction to hold this trial in Texas. During trial, the company was forced to make three mistrial motions.

The first MDL trial in October 2014 resulted in a defense verdict. In a state case in 2015, a judge in Maryland granted summary judgment in favor of DePuy and dismissed the case. DePuy has appealed the March 2016 and December 2016 MDL verdicts in favor of the plaintiffs on numerous grounds, including court rulings that undermined the company’s ability to properly and fairly defend itself.

For additional information on ULTAMET Metal-on-Metal, please visit: www.UnderstandingULTAMET.com.

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Update on ULTAMET Metal-on-Metal UK Hip Trial

In October 2017, a trial regarding the ULTAMET® Metal-on-Metal Articulation will take place at the Royal Courts of Justice in London on the question of whether the product is defective under UK consumer protection laws.

At DePuy, we have no greater responsibility than to the patients who use our products. The device is backed by a strong record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain. We are committed to the long-term defense of the allegations in this litigation.

Here are some key facts about ULTAMET Metal-on-Metal:
• In designing ULTAMET Metal-on-Metal in the late 1990s, DePuy was responding to the medical need at the time for a hip replacement option that might better meet the demands placed by younger, more active patients and that would help reduce the complications with the implants previously available.

• Since the time ULTAMET Metal-on-Metal became available, DePuy has closely monitored its performance, as we do for all our products.

• Today, the PINNACLE Cup System remains a widely used and clinically successful modular acetabular cup system for hip replacement. It allows surgeons to choose from metal-on-polyethylene, ceramic-on-polyethylene or ceramic-on-ceramic materials to replace a patient’s hip, depending on the surgeon’s clinical experience and the patient’s individual needs.

Meeting the needs of patients is at the center of what we do, and everyone at DePuy is united by the common goal of improving patients’ lives. We remain committed to advancing innovative treatment options to serve those who need joint replacement surgery.