Zimmer Hip Replacement Problems
Total hip replacement – also known as total hip arthroplasty (ATH) – is a common medical procedure performed on nearly half a million patients every year in the United States. Zimmer Holdings, Inc. designs and manufactures a variety of orthopedic products, including hip replacement devices and components. Zimmer markets its range of hip implant systems as cutting-edge medical technology, ostensibly giving orthopedic surgeons more options when selecting the most suitable prosthetic hip for their patients. A number of the devices employ metal-on-metal articulation, which has been linked to a host of severe Zimmer hip replacement problems, including increased risk of blood poisoning, tissue damage, and early failure rates.
Zimmer hip replacement products
With operations in more than 25 countries throughout the world, Zimmer designs and manufacturers several hip replacement products, such as the acetabular cup, femoral neck and stem components, and hip revision systems.
- Durom Acetabular Cup
- Trabecular Metal Modular Acetabular System
- Trilogy Acetabular System
- Continuum Acetabular System
Femoral Neck and Stem Components
- Trabecular Metal Primary Hip Prosthesis
- M/L Taper Hip Prosthesis
- Fitmore Hip Stem
- VerSys Epoch FullCoat Hip
Revision Surgery Components
- Wagner SL Revision Hip
- ZMR Hip Systems
- Trabecular Metal Acetabular Revision
Early reports of Durom Cup problems
Since its launch in mid 2006, Zimmer’s Durom Cup implant has been the source of increasing controversy and litigation, as its metal-on-metal components have sometimes allegedly proved problematic. This Zimmer hip replacement was marketed to younger patients with active lifestyles, as the device was supposed to give greater range of motion, with less wear than traditional prosthetic hips.
Composed of a single piece of cobalt chromium alloy, the Durom Acetebular Cup is designed for use with the Zimmer Metasul all-metal Triboligical Solution LDH (Large Diameter Heads). While the Durom Cup was intended to increase both durability and flexibility – two inherent weaknesses of traditional hip replacements – the device experienced a higher than expected number of early failure rates, causing some patients to undergo costly and painful revision surgery. The acetubular cup is coated with a porous surface designed to allow boney in-growth. However, according to surgeons who implanted the device, this does not always take place.
Dr. Lawrence Dorr, a nationally recognized orthopedic surgeon and paid Zimmer consultant, was among the first experts to question the safety of the Durom Cup. In 2007, he informed Zimmer that the Durom Cup was failing more frequently than anticipated because it was loosening from the bone, rather than fusing to it. The surgeon published a letter to his colleagues at the American Association of Hip and Knee Surgeons in March 2008, noting that out of 165 surgeries, 14 patients required revision surgery after only 2 years – an unexpectedly high revision rate. He stated that the Zimmer hip replacement problems he was observing were not the result of improper surgical technique, but rather poor construction of the Acetubular Cup. Loosening of the implant, inadequate fixation, and improper seating were among the early Durom Cup problems Dr. Dorr cited.
Zimmer suspends Durom Cup sales in 2008
After surgeons expressed concern over premature failure rates with the Zimmer hip replacement device, the company temporarily suspended Durom Cup sales in July 2008. According to the manufacturer’s investigation, the failures were the result of surgeon error rather than defective design. Zimmer sent a letter to orthopedic surgeons, cautioning them to stop implanting the Durom Cup until they had undertaken additional training to avoid further complications. Shortly thereafter, the company resumed sales of the Durom Cup after updating surgical instructions on its website. No Zimmer hip recall has been issued.
Since 2006, an estimated 13,000 patients have received the Zimmer Durom Cup. The FDA continues to caution about the risks of metal-on-metal implants, which have been shown to deteriorate faster than traditional ceramic or plastic models – potentially exposing patients to high levels of metal ions such as cobalt and chromium.
Ongoing Zimmer hip replacement problems
In 2011, the FDA received more than 5,000 complaints related to all-metal implants, including the Zimmer Durom Cup—more than the previous four years combined.
A 2010 article published in the New York Times noted that metal-on-metal hips could generate high volumes of metallic debris, creating inflammatory reactions that cause chronic pain, tissue death in the hip joint, and loss of surrounding bone. Though Zimmer maintains that its all-metal implants are safe, the Times noted that the company has settled a number of patient lawsuits arising from alleged Zimmer hip replacement problems.
The FDA issued an updated safety communication in March 2012, informing patients that have metal-on-metal implants to be aware of potential signs that the devices are not functioning properly.
The agency lists the following symptoms of early hip replacement failure:
- Pain in the groin, hip or leg
- Swelling at or near the hip joint
- A limp or change in walking ability
- Noise (popping, grinding, clicking or squeaking) from the hip joint
Zimmer hip lawsuits
Litigation continues to grow, as recipients of the Durom Cup file Zimmer hip replacement lawsuits in federal courts around the nation. Most of the plaintiffs had to endure painful revision surgery after suffering complications from early hip failure. Claimants are requesting compensation for past and future medical expenses, lost wages, mental anguish, and other damages related to their injuries. In 2008, Zimmer set aside $69 million to help cover claims regarding the Durom Cup.
- New York Times, (March 3, 2010) As Use of Metal-on-Metal Hip Implants Grows, Studies Raise Concerns, http://www.nytimes.com/2010/03/04/health/04metalhipside.html
- Zimmer Holdings, Inc., (July 22, 2008) Background on Durom Cup Status, http://www.zimmer.com/web/enUS/pdf/Durom_Backgrounder_on_Status_7-22-08.pdf
- Food and Drug Administration (FDA), (January 17, 2013) Recalls Specific to Metal-on-Metal Hip Implants, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures