Zimmer Hip Replacement: Is the Durom Cup Half Full, or Half Empty?

Warsaw, INThe lucrative field of hip-replacement surgery could be forgiven for inviting controversy. In the case of Zimmer, the world's largest supplier of hip replacement parts, scrutiny has been focused on the quality of their Durom Acetabular Component, known as the Durom Cup, and the naming of Zimmer along with other manufacturers in a lawsuit alleging the payment of kickback to gain competitive advantage.

Filed in US District Court in Pittsburgh on August 11th by Richard and Holly McCullough, owners of Intermedics-McCullough, the suit alleges that various companies—including Zimmer—blocked them out of the market with a host of allegedly inferior, but more costly products by offering kickbacks "for the purpose of gaining exclusive access to the lucrative replacement hip, knee and joint industry and to the orthopedic industry in general."

More than two-dozen physicians are also named in the suit for allegedly accepting kickback payments, from as little as $100 to more than $8 million.

The latter amount, in actual dollars $8,073,997 according to the lawsuit, is alleged to have been paid by Zimmer to Dr. Harry Rubash, formerly of UPMC and now Chief of Orthopedic Surgery at Massachusetts General Hospital.

A spokesperson for the US Attorney's Office in New Jersey notes that the vast majority of doctors who received payments from the various companies named, including Zimmer, had legitimate agreements in place with regard to consulting services. That said, the spokesperson stressed that the investigation is ongoing.

Meanwhile, Zimmer is under fire for its Durom Cup system, a newer type of replacement hip comprised of a single piece of material that has been used in more than 12,000 hip replacement surgeries since the Durom Cup arrived on the market two years ago.

However, last month Zimmer temporarily suspended sales after reports of severe pain and the need for additional surgeries began to flow in. A failure rate of 5.7 percent has been reported, and Zimmer halted sales after scrutinizing the data from 3000 cases.

While sales of the Durom Cup were temporarily suspended, Zimmer did not trigger a recall, but instead intended to use the suspension to update instructions with regard to special surgical techniques the manufacturer suggests is necessary for a successful outcome. To that end, the company suggested that it would offer a new training program for US surgeons working with the Durom Cup.

There was never any suggestion from the manufacturer that the appliance was defective—hence the decision not to trigger a recall—however it was reported that in April of this year a prominent orthopedic surgeon advised the American Association of Hip and Knee Surgeons that in his view the Durom Cup WAS defective. In Dr. Larry Dorr's experience with the Durom Cup 14, out of 165 surgeries required some kind of revision within the first two years of surgery.

Dorr's observations served as the genesis of a communiqué issued to healthcare providers in May with regard to an investigation undertaken by Zimmer, which ultimately halted sales in July pending a revision to surgical instructions.

In the meantime Intermedics-McCullough, an independent contractor for Sulzer-Medica Inc. with an exclusive agreement to vend Sulzer-Medica products in the western regions of Pennsylvania and West Virginia, contends that the kickback scheme allegedly involving various defendants, including Zimmer, and involved high-priced products that were, in its view, inferior.

Zimmer has advised doctors and patients to be aware of any pain that begins more than three months after surgery. It is not known if the manufacturer plans to extend financial aid to patients who need revisionist surgery after receiving a Durom Cup, nor is it known how many participants would be involved in a possible class-action lawsuit.

That number could be at least 684…