Durom Cup Hip Replacement Creates Quite a Rub

Pete Strom — Tue, 07 Jul 2009 17:35:25 GMT

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.

http://www.youtube.com/watch?v=ipUrar7h90w

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.

Originally posted at InjuryBoard by Pete Strom

Hospital Bracelets: Helpful or Hazardous?

Amanda Schlager — Fri, 26 Sep 2008 14:53:30 GMT

Although the plastic bracelets hospitals adorn their patients with may be colorful, they are designed to indicate special patient conditions, rather than make a fashion statement.

The national movement to standardize the color-coded bracelet system used in hospitals started in New York. After an infamous Pennsylvania case in 2005 in which a nurse mistook a yellow wrist band for meaning “restricted extremity”, its meaning at another hospital at which she worked part-time, with what it meant at that hospital, D.N.R. or “Do Not Resuscitate.”. The potential for dangerous mix-ups such as this have pushed hospitals to standardize coding systems.

Over 20 states have embraced the color-coding system, which is also endorsed by the American Hospital Association.

Although this system sounds logical, some agencies have expressed concerns about the bracelets and patients’ privacy rights. The Joint Commission has referred to this practice as “branding patients by their end-of-life choices”. The Executive Vice President of the Continuing Care Leadership Coalition, Roxanne Tena-Nelson, suggests “strik[ing] a balance between the need for patient safety and accuracy and the whole privacy concern and sensitivity and compassion for the patient.”

Hospitals are also running into problems with bracelets patients bring from home, like the yellow Lance Armstrong “Livestrong” bracelet. While some hospitals request patients cut these bands off, a bracelet left on a patient’s wrist could create a confusing hazard.

If you are a diabetic, have allergies to certain medications, or have unique issues that would be vital at a time when you are unable to communicate to a health professional, you should consider purchasing an alert bracelet. Medic Alert is one company that makes such bracelets but you can order from many providers online.

A custom bracelet, usually made out of aluminum or silver (a material that can be engraved with personal information), is not likely to be confused at the hospital and can provide valuable, life-saving information in the event that you cannot communicate with healthcare providers. Furthermore, wearing an alert bracelet with the universal medic sign (large, red plus sign) can put a doctor on notice as to special conditions you may have. Should the doctor ignore the bracelet, and you are injured as a result, that could be evidence in a medical malpractice case.

Originally posted at InjuryBoard by Amanda Schlager

Columbia Personal Injury Lawyer - Medical Devices & Implants

Durom Cup Hip Replacement Creates Quite a Rub

Hospital Bracelets: Helpful or Hazardous?