Zimmer Durom Cup Problems Draw Warning in New Zealand

New Zealand health officials are warning about a risk of problems with Zimmer Durom metal-on-metal hip replacement components, which may pose a hazard for patients. 

Medsafe, the New Zealand health regulatory agency, issued an international hazard alert on October 26, indicating that the Zimmer Durom Acetabular Cup has a higher number of failures than similar devices.

There were only 252 Durom hips implanted in New Zealand before its use was discontinued in June 2011. However, thousands of the components have been implanted in patients in the United States.

Medsafe estimates that about 16% of all individuals who received the Zimmer Durom hip will experience problems within 10 years, which is higher than the 10% average failure rate seen with metal-on-metal hip replacements in general.

To date, Medsafe has issued at least four other similar warnings about specific metal hip implants, including the DePuy ASR, DePuy Mitch TR, Smith & Nephew R3, and Smith & Nephew Birmingham hips.

“There is greater awareness by manufacturers and regulators about these devices, which is why we are seeing more of these alerts,” said Medsafe Group Manager Dr. Stewart Jessamine in the hazard alert. “Regulators around the world, including Australia, have responded in a similar way as Medsafe to the finding that some hip device products have higher revision rates.”

Metal-on-Metal Hip Replacement Problems

Although metal-on-metal hip replacements quickly grew to account for a large share of the artificial hip implant market over the past decade, concerns over the long-term safety of the devices have increased in recent years, leading to a sharp drop in sales for all metal designs for total hip replacements.

The devices have been found to be prone to loosen and fail prematurely due to the release of metal debris as the parts rub against each other during normal use. As a result, a high percentage of individuals have required revision surgery within a few years, to replace the devices after developing metallosis, or metal blood poisoning.

In June 2012, the FDA convened a panel of independent experts to review the risk of problems associated with metal-on-metal hips. The panel determined there is little, if any, benefit provided by using metal-on-metal hips, and indicated that individuals who previously received one of the systems should obtain regular examinations to check on the condition of the hip, even if they are not experiencing problems. Those who develop symptoms of pain or other complications have been urged to obtain annual blood tests for signs of metal blood poisoning.

Temporary Zimmer Durom Cup Recall Was Issued In United States in 2008

The Zimmer Durom Cup hip implant was first introduced in the United States in 2006, with a design that was supposed to avoid many problems associated with traditional hip replacement components, such as instability, limited range of motion and wear of the bearing.  However, shortly after it was introduced, concerns emerged about a high number of hip replacement failures with the Zimmer Durom Cup, where the component loosened and required revision surgery.

A temporary Zimmer Durom Cup recall was issued in July 2008, so that revisions could be made to the product’s warnings and instructions to ensure that doctors were properly trained on the surgical techniques needed to implant the artificial hip correctly.

In the U.S., about 12,000 people received the Zimmer Durom Cup between 2006 and 2008. The company faces a number of Zimmer Durom cup hip lawsuits brought by consumers who received the implant before the temporary recall.

In June 2010, all federal lawsuits over the Zimmer Durom Cup were consolidated for pretrial proceedings in the U.S. District Court for the District of New Jersey as part of an MDL, or multidistrict litigation.

While some settlement agreements have been reportedly reached, the litigation is continuing in a large number of cases that are being prepared for potential trial dates.