Wright Medical Questioned About Hip Implants

Wright Medical Group Inc. has received a subpoena from the Western District of Tennessee U.S. Attorney’s office requesting 11 years worth of records regarding the company’s Profemur series of hip-replacement devices.

According to court documents, on Aug. 17, 2011, Terrance Allore and his wife Rebecca filed a lawsuit in Michigan Eastern District Court alleging that his Wright Profemur hip replacement failed less than three years after it was implanted causing him severe problems.

Digital Journal reported in October that year that Virginia Welch of Mesa, Ariz., filed a lawsuit against the company claiming her Profemur Z hip replacement had failed within three years of its implantation as well.

“According to 2009 data reported by the Australian Orthopaedic Association, Wright Profemur stems demonstrated an 11.2 percent failure rate at three years following the surgery to implant them,” Welch’s attorney Paul D. Friedman told Digital Journal. Welch had her hip replacement removed in November 2009.

A search of the U.S. Food and Drug Administration (FDA) MAUDE database, which is a collection of adverse event reports, turns up 1,160 results for Wright’s Profemur implant.

The subpoena requests “records and documentation” on Profemur products between Jan. 1, 2000, and Aug. 2, 2012. Wright officials said in a statement that the subpoena “is not an allegation of wrongdoing or product safety issues” and does not impact the company’s ability to sell the devices.

“We are cooperating with the U.S. Attorney to provide the requested information,” a company spokesperson said.

Wright’s Profemur hip systems are made of a titanium alloy. Metal-on-metal hip systems have been under scrutiny lately due to high failure rates, and the FDA has reported approximately 16,800 adverse events related to metal-on-metal hip implants in the United States from 2000-2011. Stryker just recalled its Rejuvenate and ABG II Modular-Neck Hip Implant Stems in July, though their implants were made of a softer titanium alloy that is touted to be more flexible, more closely imitating bone. However, there is very little scholarly scientific information and research available for the alloy, known as TMZF, that Stryker uses. Most citations Stryker uses on its website are data collected by Stryker Orthopaedics engineers and scientists. The Stryker devices were recalled due to risk of corrosion. Analysts predicted the recall would spell trouble for Wright Medical’s similar hip system.

DePuy Orthopaedics Inc., a Johnson & Johnson company, faced more than 2,000 lawsuits in state and federal court since the recall of its ASR hip system in August 2010. Zimmer Holdings Inc. suffered a blow in mid-2008 when it suspended U.S. sales of a metal hip cup called Durom amid reports of issues including cup loosening, which the company pegged on surgeons needing retraining.

Wright Medical is based in Arlington, Tenn. The company designs and manufactures reconstructive joint devices and biologics.