Zimmer Durom Hip Cup

In 2007, renowned orthopedic surgeon, Dr. Lawrence Dorr,  noticed that something was going wrong with his hip-replacement patients.  Patients who should have been living pain-free after their hip replacement surgeries were in agony instead.  A veteran of more than 5,000 hip surgeries,  Dr. Dorr knew something was amiss.  All the patients that were experiencing problems had been implanted with Durom Cup hip replacements manufactured by Zimmer.  14 of his 165 patients implanted with the device needed a replacement within months of their first surgery.

When Dr. Dorr’s worries were ignored by the company, he took matters into his own hands by drafting a letter to his fellow members of the American Association of Hip and Knee Surgeons warning of the failures and defects associated with Zimmer’s Durom hip cup. He found that many of his colleagues and many other hip replacement patients were having similar problems with the Zimmer Durom hip cup. The devices were failing at an unusually high rate, and leaving patients with pain and the need for an additional invasive,  replacement surgery.

Dr. Dorr’s letter prompted an internal investigation and eventually an FDA recall of the Durom hip cup devices.

Problems with the Durom Hip Cup

The Durom hip cup is intended for use in patients needing a total hip replacement.   The outside shell of the Durom cup is porous and coated with a special substance.  The cup is supposed to bond with the pelvis, allowing the bone to grow around the device and hold it into place.  However, what Dr. Dorr and many other doctors and patients found was that the Durom cup was not fusing with the bone, but rather coming loose and causing extreme pain as the metal device moved and rubbed against the bone. 

Some patients who were implanted with the Durom Hip cup needed a second, corrective surgery –many within two years of their first hip replacement surgery.  The external coating of American cup is thicker than in devices sold in other countries, leaving some doctors to believe that the failure rate is linked to the faulty fixation surface of the American version of the cup.

Symptoms of a Durom Hip Cup Problem:

• “Start-up pain or stiffness” –pain or limping experienced when rising from a chair, getting out of a vehicle, etc. for more than 10 steps
 
• Antalgic hip limp –  a style of walking used to minimize pain that is characterized by a rapid, heavy step, followed by a slower step on the unaffected side of the hip
 
• Sharp, intense pain when moving from a bent position to an upright position
 
• Difficulty using stairs
 
• Lack of endurance and/or difficulty walking 100 yards
 
• Use of a cane or walker
 
• Experiencing one or more of the symptoms above 3 or more months after undergoing to hip replacement surgery

Zimmer Stands By Its Product, Blames Doctors

In 2008, Zimmer announced that it would temporarily discontinue marketing and distribution of the Durom cup within the United States.  The company also confirmed that a number of Durom cup patients would require replacement surgeries or new surgeries in order to correct the problem.

At the time of the recall, Zimmer stood by the effectiveness of its product and indicated that some fail rates could be attributed to doctors not having adequate training in how to properly install the devices – surgeons like world-renowned orthopedic surgeon Dr. Lawrence Dorr – and vowed to revise its surgical technique instructions and surgical training programs.

In a release, Zimmer said,
While many U.S. surgeons have had success implanting the Durom Cup, a subset have experienced elevated revision rates since the product was launched in the U.S. in 2006. These results contrast with product experience in Europe, where post-marketing data continue to show excellent clinical outcomes since the product launched in 2003. 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 has identified that surgeons who regularly achieve the desired outcome with the Durom Cup consistently execute crucial technique steps and place the cup in a specific manner. 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 has shared its review and conclusions with the U.S. Food and Drug Administration (FDA) and will continue to update the Agency.

Not everyone was as convinced of the effectiveness of Zimmer’s Durom cup, including Zimmer’s own investors who filed a class action lawsuit for damages for shareholders.  The suit alleged that Zimmer made material misrepresentations by failing to disclose problems arising from the use of the Durom Cup, and failed to disclose material flaws in the quality systems at a manufacturing facility, where the orthopedic surgical products were made.

Zimmer Durom Cup Lawsuits

In October of 2008, Zimmer announced that it would set aside $47.5 million dollars for potential lawsuits resulting from Durom Cup failures.
The experienced medical device litigators at Neblett, Beard & Arsenault are currently investigating claims against the manufacturer of Durom hip cups.  If you or a loved one were implanted with a Durom hip cup and now are experiencing symptoms of the implant failing or loosening, you may be entitled to compensation.  The law limits the time you have to file a claim, so speak to an attorney now by calling 1-800-256-1050 or submit an online case evaluation form.

Additional Resources:

Dr. Dorr’s Letter to the American Association of Hip and Knee Surgeons
FDA Recall

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