Durom Cup Hip Replacement Creates Quite a Rub
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What’s worse than a bad hip that slows you down, impedes your lifestyle, and eventually forces you to have hip replacement surgery? Having that hip replacement surgery, being left with more pain and facing the prospect of additional surgery.
Approximately 442,000 patients undergo Total Hip Arthroplasy (THA) or total hip replacement in the United States each year. A THA is designed to help relieve pain and improve joint function in people with severe hip degeneration due to arthritis or trauma.
A common problem with THA implants is balancing the desire for an active lifestyle with the product’s design. Historically, replacement devices have not worn well and have created range of motion and stability issues. The Durom Acetabular Component “Durom Cup” was introduced for young patients who will outlive a traditional hip replacement, hoping to improve range of motion and lower the risk of dislocation, complications of traditional replacement devices. The Durom Cup has been implanted in over 12,000 patients since it was first sold in the United States in 2006. Despite its lofty intentions, the cup has a purported 23% failure rate, forcing many patients to endure severe and crippling pain and ultimately undergo additional surgery.
The first surgeon to discover the problem was Dr. Lawrence Dorr, who ironically was a paid consultant for Zimmer. The Company responded by alleging that Dr. Dorr, who had over 30 years experience implanting THA’s, was not following correct procedures in implanting the hip replacement device. After other doctors complained, Dr. Dorr launched an aggressive campaign including an instructional program intended to help doctors understand how to implant the device. Despite being aware of the allegations, Zimmer waited for several months until it suspended distribution, during which time an additional 1,300 patients had the cup inserted.
In July 2008, Zimmer Holdings, designer and manufacturer of the Durom Cup, finally announced that it was temporarily suspending marketing and distribution of its product until it can provide updated labeling, more detailed surgical techniques and training programs for surgeons. The company continues to claim that the product is not defective and claims it is the ultimate responsibility of each doctor to receive more training on how to insert the device. Despite its denials, the company has set aside a fund to address claims that the device is defective.
So What’s the Problem?
The largest concern with the Durom Cup is loosening of the cup itself. After the material of the bearing begins to wear, the cup pops from the socket with little effort. The cups can also migrate inside the body so they are no longer in the correct position. A second surgery is then needed in order to correct the problem. Additional concerns include a risk of the metal component of the hip implant failing to bond property with the existing bone. Instead of bonding, the metal socket loosens and separates, resulting in severe pain and device failure, requiring an expensive and painful revision surgery for patients.
Studies conducted by Zimmer at international clinical sites have revealed that revision rates for the device, or rate of subsequent required surgeries, range from 1.5% to 5.7%. A similar study conducted by Dr. Dorr, the surgeon and consultant who formerly worked with Zimmer and first reported the issue, found a failure rate of 23%.
If you had a hip replaced, and have experienced the following warning signs after the typical three month recovery period:
· start up stiffness and pain when you rise from a chair or out of a car;
· sharp groin pain when moving from a bent position to an upright position or when lifting your leg straight when lying down;
· difficulty climbing stairs;
· inability to walk distances; or
· reliance upon a cane when walking outdoors,
you should contact an experienced Durom Cup attorney.
Strom Law Firm is a personal injury and criminal defense law firm centrally located in Columbia, South Carolina. Our firm proudly handles personal injury, criminal defense, defective products, class actions, pharmaceutical liability, toxic torts, medical malpractice, nursing home neglect, workers compensation, social security, veteran's benefits, qui tam, predatory lending, tax investigations, business litigation, and wills and estates. Our lawyers proudly edit the Columbia, South Carolina Injury Board as well as the Strom Law Blog as a pro bono effort to provide the public valuable information. Our lawyers are licensed in: South Carolina, New York, Georgia, Florida, and the District of Columbia.