The Zimmer Hip Recall: What’s In A Name And Who is to Blame?
In July 2008, Zimmer Inc. suspended sales of the Durom Acetabular Component or Durom Cup, a popular hip replacement device, due to high revision rates experienced by patients fitted with the device because of hip implant failure requiring hip revision surgery.
Zimmer hip recall or Zimmer hip suspension of sales
The action was not a Zimmer hip recall, as had been widely reported, but more accurately a Zimmer hip suspension of sales.
Three months after pulling the Durom Cup from the US market, Zimmer again cleared orthopedic surgeons to fit patients with the device.
There remains controversy about why Zimmer Inc., one of the largest orthopedic device manufacturers in the world, initiated a Zimmer hip suspension of sales.
Dr. Larry Dorr – Zimmer hip replacement surgeon
and former Zimmer spokesman
Dr. Larry Dorr of the Dorr Arthritis Institute was one of the first surgeons to report problems with the device. Dr. Dorr is an experienced hip replacement surgeon whose name and profile still appear on the official Zimmer.com web site. In April 2008, Dr. Dorr wrote a public letter to the American Association of Hip and Knee Surgeons, reporting a revision rate of nearly 8.5 percent within just two years among Durom Cup recipients.
Dr. Dorr cited shortcomings with the seating mechanism as the source of the Durom Cup’s problems.
Zimmer disagreed. In a July 22, 2008 “Dear Surgeon” letter, Zimmer reported the results of a study that involved more than 3,000 Zimmer hip recipients, concluding, “No evidence of a defect in the materials, manufacture or design of the implant has been found.
Dr. Dorr’s technique and the surgical techniques of dozens of other physicians were to blame for the high revision rate, according to Zimmer.
“The results of our in-depth investigation have led us to conclude that additional surgical technique instructions and training are necessary in the United States, and we strongly recommend that U.S. surgeons stop implanting the Durom Cup until receiving such training.”
At the time of the Zimmer hip suspension of sales, more than 12,000 Americans had received the Durom Cup hip replacement system. Many of those patients were implanted with a device that, according to Zimmer’s own statement, surgeons were not fit to implant.
Dr. Dorr on the Zimmer hip suspension of sales –
“It is bad design.”
Dr. Dorr, who had undertaken thousands of successful hip replacement surgeries, never doubted his technique. On July 24, 2008, The New York Times published an article reporting the temporary Zimmer hip recall. In it, Dr. Dorr says of the Durom Cup: “It is a bad design.”
On August 16, 2008, Zimmer again began marketing the Durom Cup with updated labeling. Today, the Durom Cup continues to be sold in the US and around the world.
Zimmer hip multidistrict litigation
In June 2010, the Judicial Panel on Multidistrict Litigation approved of the consolidation in a single New Jersey court of widespread legal action against Zimmer. At the time, 45 Zimmer hip lawsuits had been filed in federal courts. Scores have since joined the litigation, as reports surface that Zimmer has sought to reach valuable settlements with Durom Cup recipients.