Zimmer Hip Lawsuit – Recall, Warnings, Lawsuits
Zimmer’s Durom Cup, a metal-on-metal hip replacement, first received FDA approval in March 2006. Within a short time, the reporting of adverse events got the manufacturer’s attention. Though the company never issued a Zimmer hip recall, it did temporarily suspended sales of the product in 2008 only to reintroduce the model within months.
Since then, momentum has continued to build against the hip replacement implant manufacturer with many recipients seeking relief via the filing of a Zimmer hip lawsuit. Plaintiffs claim a variety of hip complications that have sent many back to the operating room for revision surgery. Zimmer has reportedly set aside more than $270 million to settle the pending claims.
Zimmer hip replacement problems
The Durom Acetabular Cup is a metal-on-metal hip replacement. One of the serious risks associated with the product’s design is the possibility of metallic parts rubbing together, causing metal to flake off and enter the bloodstream. Metal in the bloodstream is known as metallosis or heavy metal poisoning, a serious condition that can cause serious damage to body tissue.
Another serious complication associated with the implant occurs when the device fails to bond with the bone. The Durom Cup is covered in a porous coating that is meant to encourage natural bonding as the hip bone grows into the device surface. If the bond never takes, the patient will likely experience hip implant failure and may ultimately need to have the device replaced. Zimmer hip revision surgery can be costly, painful, and expose the patient to all risks of surgery without a guarantee of success.
First signs of trouble
Dr. Larry Dorr, a renowned orthopedic surgeon and former consultant for Zimmer was one of the first surgeons to question the safety of the Durom Cup. In 2007, Dr. Dorr alerted Zimmer of the problems he observed with regard to the device. According to the doctor, the implants were failing because they failed to fuse properly with the bone forcing many patients to have hip revision surgery.
In March 2008, Dr. Dorr published a public letter to his colleagues, other orthopedic surgeons who worked with the product. In the letter, the surgeon detailed a small sample size of hip replacement problems: Of Dr. Dorr’s 165 implant surgeries, 14 patients had undergone early revision surgery within two years.
At around the same time, a study published in The British Medical Journal (BMJ) analyzed 18 hip implant studies, in total reviewing 3,139 patients and more than 830,000 operations. Among the most striking results was the finding that metal-on-metal hip implants appeared to be no better than traditional hip implants at improving and furthering patients’ quality of life. Implant superiority had been a major component of metal-on-metal device advertising. Furthermore, 17 of those 18 studies showed that metal-on-metal implants had higher rates of hip dislocation. One study also found high concentrations of chromium and cobalt in only Durom Cup recipients, causing researchers to conclude that the problem was the Durom Cup itself, and not metal-on-metal hip implants in general.
Zimmer suspends sales; FDA releases warning
After Dr. Dorr’s letter was published, Zimmer enacted a temporary product suspension in July 2008. Notably, this was not a Zimmer hip recall, but merely a reassessment of the product. Zimmer ruled that any failures were due to surgeon error. They re-released the Durom Cup with new, allegedly more precise instructions for surgeons. Nevertheless, in 2011, three years after the implant’s suspension, the FDA received more than 5,000 metal-on-metal hip implant complaints – including for Zimmer’s Durom Cup.
As a result of consumer complaints, the FDA released a warning for metal-on-metal implants, including the re-released Durom Cup. The federal agency warned that these implants are not suited to every patient, and that only your surgeon can determine whether you are a good candidate to receive such a product.
Patients who meet any of the following criteria should never receive a metal-on-metal implant:
- People with a weakened or suppressed immune system
- Patients of child-bearing age
- Recipients suffering from kidney problems
- People who are sensitive or allergic to metals
- Patients on high doses of corticosteroids
Durom Cup problems prompt claims for compensation
After the 2008 suspension of sales, Zimmer reserved $271.7 million to compensate plaintiffs for their Zimmer hip replacement problems. These patients would eventually require revision surgery to either repair or replace their faulty Durom Cup implants.
On June 9, 2010, plaintiffs from around the United States who had filed a Zimmer hip lawsuit had their claims consolidated into federal multidistrict litigation (MDL). The MDL is headquartered in the U.S. District Court for the District of New Jersey. As of November 2011, Zimmer estimated a remaining liability of $142.6 million. The company expected to settle the majority of remaining complaints within three years – by the end of 2014.
File a Zimmer hip lawsuit
Individuals who have suffered complications and injuries from the Durom Cup still have time to file a Zimmer hip lawsuit. Recipients of Zimmer hip implants who experienced metal contamination, device loosening or early failure and those who required corrective surgery may be eligible for significant financial damages. At present, Zimmer hip lawyers are offering free case evaluations to help patients determine their legal options and right to compensation.
- Zimmer.com: Questions and answers on hip replacement and metal-on-metal systems http://information.zimmer.com/en/
- FDA recalls for metal-on-metal hip implants http://www.fda.gov/MedicalDevices/ProductsandMedical