A man has filed a civil action against Zimmer Holdings, Inc., and Zimmer, Inc. contending products liability allegations against the makers of the Zimmer Durom hip implant.

Plaintiff Scott F., a resident of Texas, alleges that he was implanted with a defective artificial hip and replacement system known as the Durom Acetabular Component. The Zimmer Durom hip implant cup was manufactured, labeled, and sold to the plaintiff by Zimmer.

Scott alleges claims of products liability, negligence, breach of warranty, fraud, and further damages sustained by him due to the defective hip socket device.

The plaintiff alleges that Zimmer had failed to recognize deficiencies of the Durom cup and failed to provide adequate quality assurance procedures.

He maintains of Zimmer that the company, “failed to implement or utilize adequate safeguards, tests, inspections, monitoring, and quality assessments to ensure safety of the defective device,” the lawsuit maintains.

According to the Zimmer Durom hip implant lawsuit, the plaintiff alleges that, “at the time the devices were manufactured and sold to patients, the devices were defectively manufactured and unreasonably dangerous, and did not conform to the federal regulations subjecting patients to risks of injury.”

The complaint alleges that the Zimmer Durom hip implant device, or cup is a metal-on-metal hip implant system, and at the time of its manufacturing and marketing Zimmer had claimed that the medical device was more durable and would provide more hip range of motion and less wear and tear than previous and traditional hip implant devices.

However, because of its implantation, Scott says he suffered serious adverse and formidable effects. According to the hip implant lawsuit, the plaintiff suffered alleged significant injuries due to the implantation of the Durom Cup in his left hip.

Scott alleges that because of the cup’s failure he sustained discomfort, soreness, and debilitating pain after its insertion.

Soctt had the Zimmer Durom hip implant cup surgically inserted in November 2006. After a period of ongoing pain, the plaintiff alleges that he was advised by his physician to have the Durom Cup removed and to undergo revision surgery. The device was removed and the revision surgery was carried out in April 2016.

The claims made assert that the Durom Cup does not function in its intended manner. The Durom Cup allegedly resists bone growth, and this causes it to become loose and unattached from the hip, instead of adhering to the bone as marketed to do.

The result is damage to the pelvic bone, which leads to extreme and debilitating pain and necessitates revision surgery to replace it with a functional device, as was the case with Scott.

The Durom Cup was first sold in the U.S. in 2006 and cleared by the FDA for distribution and marketing, but it was suspended from sale in July 2008.

The FDA had approved its distribution as a part of a “me too” application process known as the 510 (k) approval process. They had contended that it had the same qualifications and safety and effectiveness as other products on the market at the time.

According to the hip implant lawsuit, no clinical studies were conducted in association with the Durom Cup’s application process.

Scott alleges that the defendant’s non-clinical analysis demonstrated “that the device is safe and effective and substantially equivalent to the predicate device (as implants).” He further claims that between 2006 and 2010 there was an estimated failure rate of 24% when patients had been implanted with the Durom Cup.

Scott says the defendants had promised, marketed, and sold the hip socket device under the representation that it would provide increased range of motion and less wear and tear. He says he suffered and will continue to suffer pain and hospital/rehabilitative medical expenses.

The Zimmer Durom Hip Implant Lawsuit is Case No. 2:17-cv-03521, in the U.S. District Court for the District of New Jersey.

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