Sunday, November 4, 2012

Zimmer pulls metal-on-metal Durom acetabular hip implants from Australian market

Mass Device

In another blow to the metal-on-metal hip implant market, orthopedic giant Zimmer Holdings (NYSE:ZMH) canceled its Durom Acetabular Component from the Australian Register of Therapeutic Goods, the regulatory agency announced this week.
The implant, which had virtually faded from use already, was pulled after data showed that it was responsible for higher revision rates compared with similar devices.

Data from the Australian National Joint Replacement Registry found that the Durom components were associated with a 9.6% cumulative revision rate at 7 years when used in hip resurfacing and a 6.8% rate at 5 years when used in total hip replacement.

Similar devices had a 7-year resurfacing revision rate of 6.1% and a 5-year total hip replacement revision rate of 3.6%, according to the ARTG notice.

Zimmer issued a "hazard alert" to physicians who had implanted the device, but the ARTG noted that the Durom components aren't particularly popular anymore.

The Durom acetabular implant had declined in use in Australia since 2005, and the last recorded implant with the device took place in June 2011, according to the agency.

"In response to the ongoing discourse within the global orthopedic community and public discussion about metal-on-metal articulations, demand for these systems has declined substantially," Clark told us via email. "In the majority of markets globally, Zimmer's customers are requesting alternative products and it is no longer commercially viable for the company to offer these systems."

It's not the 1st time the Durom acetabular component has had to come off the shelves. In 2008 Zimmer pulled the device from the U.S. market for a period of about 1 month while it investigated "certain reports of an unusually high rate of revision," according to a regulatory filing from March 2008.

"While many surgeons have had success implanting the Durom Cup since it was launched in the U.S. in 2006, a subset have reported cup loosenings and revisions of the acetabular component used in total hip replacement procedures," according to a company statement from July 2008. "Following a comprehensive review of clinical experience and product conformance to specifications in the U.S. and Europe, Zimmer has found no evidence of a defect in the materials, manufacture, or design of the implant."

The company ultimately attributed the increased failure rates to inadequate surgical techniques, and set about investigating what techniques resulted in best outcomes for patients.

"Following its review, Zimmer has determined that revised surgical technique instructions and a surgical training program are required to more consistently achieve desired clinical results in the U.S.," the company said at the time.

The implants were suspended from July to August 2008 to give Zimmer time to "update product labeling and implement a surgical training program in the U.S.," according to a separate filing issued in December 2008. There were more than 19,000 Durom cups distributed in the U.S. at the time, according to the FDA, which gave the recall a Class II label.

The company also recorded a $69 million provision in its 2008 annual report for estimated liabilities related to a clutch of patient claims for reimbursement and for costs associated with pain and suffering due to the Durom device, which was "integral" to the company's strategic entry into the U.S. hip resurfacing market.

The device may not play a big role in the company's sales any longer, but the device is not quite out of mind yet. Patients continue to file lawsuits against the Durom device, including one such case filed less than 2 months ago in the Arkansas Eastern District Court.

The patient in that case had Durom implants in both hips, and claims that he suffered complications in both legs and his back that left him with difficulty standing and walking, according to a press release from legal services coordinator AttorneyOne.

Earlier this year the Durom implant was included alongside hip implants from orthopedic rivals Smith & Nephew (FTSE:SN, NYSE:SNN) and Johnson & Johnson (NYSE:JNJ) in a report that claimed that the metal-on-metal hips exposed hundreds of thousands of patients to toxic compounds as they components eroded over time, causing tissue and bone death and possibly exposing patients to the risk of developing cancer or even altering their DNA.

A later study of the U.K.'s National Joint Registry found no increase in cancer rates among metal-on-metal hip implant patients at 7 years.

The new moves in Australia are another bad sign for metal-on-metal hip implants as a class, which are already at the center of a growing controversy that threatens to ensnare some of the world's largest medical device makers. As the legal fallout over recalled metal-on-metal hip implants continues to grow, even devices that have avoided a recall so far have become targets for lawsuits, such as Smith & Nephew's (FTSE:SN, NYSE:SNN) Birmingham Hip Resurfacing implants.

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