Zimmer Hip Replacement Lawsuit - Durom Cup Metallosis

Another Zimmer Hip Replacement Lawsuit Added to MDL

Steve Cid | December 9th, 2014

Zimmer Hip FDA Implant ProblemsZimmer Holdings, the manufacturer and distributor of the Durom Cup hip resurfacing prosthesis, has been hit with yet another hip replacement lawsuit as part of the ongoing litigation in federal court.

In this case, Ms. Patty Jannusch, a Wisconsin woman, had the Durom Acetabular Component, also known as the Durom Cup, implanted in February, 2008, in what were to be routine hip arthroplasties (both hips replaced). At that time, neither Ms. Jannusch nor her physician were “told, warned, or given any information” about the risks of the use of the Durom Cup, a metal monoblock alloy of cobalt chromium. It was intended for use with the Zimmer Metasul Metal-on-Metal Tribological Solution LDH, providing a total metal hip replacement device that was durable and had larger diameter heads for maximum range of motion.  This metal on metal system would allow for a greater range of motion for younger, more active candidates than earlier components.

In late 2013, Ms. Jannusch developed pain in both hips. In the course of many tests to ascertain the cause of the pain, elevated levels of cobalt and chromium consistent with corrosion and debris from the metal on metal hip joints were found, a condition known as metallosis. As a result, it was determined by her physician that the best cause of action for Ms. Jannusch was to undergo revision surgeries for both hips, first on her left hip, and then on her right hip in late 2014 /early 2015 to remove the defective hip replacement devices.

Durom Cup separates from hip socket

Her Zimmer hip replacement lawsuit is currently consolidated in United States District Court for the District of New Jersey as part of the Durom Cup Products Liability Litigation, MDL No. 2158 in front of Judge Susan D. Wigenton. The common allegation is that from the time that Zimmer began aggressively marketing the Durom Cup, its product information or labeling contained no warning to either the public or the medical community that the Durom Cup could loosen and separate from the hip socket in patients, causing severe pain and prompting revision surgery.

Zimmer hip replacement failure rates

Zimmer Holdings was founded in 1927 and at over $4 billion in sales in 2008, commands enormous market share in the design and manufacture of orthopaedic reconstructive, spinal, and trauma devices, dental implants, and related orthopaedic surgical products. When the purchase of Zimmer’s most recent acquisition target, the joint manufacturer Biomet, is completed in 2015, it will make Zimmer the No. 2 orthopaedics maker in the country.

Zimmer makes twelve different hip replacement components, but the Durom Cup has continued to vex Zimmer with high failure rates as high as 30% being reported. These failures have caused “…personal injury, significant pain, and loss of movement, and that this injury can only be remedied through subsequent revision surgery and/or hip replacement”.

Unfortunately for the plaintiff in this case, her Durom Cup implants were done in February 2008, just months before Zimmer temporarily stopped sales of the device. The FDA says the recall was because “instructions for use/surgical technique instructions were inadequate.”

Zimmer blamed the surgeons performing the implants for not following directions properly and returned the Durom Cup to the U.S. market despite its problems after updating the product labeling.

Durom Cup lawsuit one of thousands

In her suit, the plaintiff, Ms. Jannusch, demands damages from Zimmer because she “…has suffered and continues to suffer serious and permanent non-economic and economic hardship”.

In a 2012 SEC filing, Zimmer acknowledged paying nearly $400 million in claims relating to Durom Cup products. It expects that future settlements to thousands of complainants will easily top a quarter of a billion dollars.

Fort Wayne Gazette, Why Not Warranties on Hips and Knees? http://www.journalgazette.net/article/20141123/BIZ/141129801