DePuy® Orthopaedics, Inc. – ASR Hip Implant Recall

DEPUY® ORTHOPAEDICS, INC.

 ASR HIP IMPLANT RECALL

IMPORTANT INFORMATION FOR PATIENTS WHO HAVE HAD HIP REPLACEMENT SURGERY

RECALLED DEVICES 

■ ASR XL Acetabular System■ (Traditional hip replacement available worldwide)

■ ASR Hip Resurfacing System■ (Partial hip replacement available in countries outside theU.S.)

DATES FOR HIP IMPLANT RECALL

Hip Replacement Surgery performed July 2003 – August 2010

The ASR XL Acetabular System is a traditional hip replacement which uses a shallow Metal-on-Metal hip design.

The ASR Hip Resurfacing System is a partial hip replacement that involves placing a metal cam on the ball of the femur which is designed to preserve more bone.

Both of the medical devices were recalled based on data from a study in the United Kingdom showed the products were failing at a higher rate than expected causing patients to undergo a second surgery know as Revision Surgery.

SYMPTOMS OF DEPUY® IMPLANT FAILURE

The metal on metal bearing design can cause excessive heat and friction, generating metal (Cobalt and Chromium) debris which can be released into the body. Failure of the DePuy® Hip Implant can causeLoosening, Misalignment & Fractures

COMMON SYMPTOMS ASSOCIATED WITH DEPUY® IMPLANT FAILURE:

  •  Severe pain in hip, groin, leg or lower back
  • Clicking, popping or crunching sounds in area of ASR device
  • Hip fractures or hip dislocation
  • Difficulty standing, moving or walking
  • Swelling or necrosis
  • Infection
  • Difficulty doing normal physical activities
  • Muscle, tissue or nerve damage in the hip groin or leg area
  • Metal sensitivity

FREQUENTLY ASKED QUESTIONS FOR DEFECTIVE DEPUY® ASR XL HIP REPLACEMENT

What should I do if I had hip replacement surgery?

Immediately contact your physician, orthopaedic surgeon or the hospital where you had your surgery, even if you are not having any pain.  Your doctor will evaluate how your implant is functioning. You should continue to follow instruction for your treatment or rehabilitation regimen. It is a good idea to write down any pain or symptoms you may be having.

How will the doctor know if the ASR implant is defective?

The doctor will need to order X-Rays, an MRI, and blood tests to check for signs of microscopic metal particles around the implant.

Will I be asked to sign anything?

Patients who received a DePuy ASR XL Acetabular or a DePuy ASR Hip Resurfacing System should receive a letter from DePuy informing them of the recall. Even if you have taken steps to initiate a claim, DO NOT SIGN any documents from DePuy, and DO NOT SIGN a release for your surgeon. These documents may affect any legal action you may want to pursue.

What is Revision Surgery?

In some cases the ASR system implant device may loosen, resulting in the device detaching from the bone, infection, or dislocation of the device’s components.

When a device is failing, you may experience unexplained and intense pain in your hip, thigh or groin. If you have severe pain when you stand up, walk, or carry weighted objects, these may also be signs your implant is failing.

Revision Surgery may be required to correct the problem. Your orthopaedic surgeon will have to remove and replace the defective DePuy implant with another device. The procedure is difficult because there is less bone for the surgeon to work with after the first implant surgery. Consequently, Revision Surgery can result in more complications, more pain and more recovery time.

Why were the ASR devices recalled?

The first problems with the DePuy ASR System were documented by the Australian National Joint Replacement Registry in 2008. Because the evidence showed a very high rate of failure concerning the device,Australiawithdrew he device from the market in December, 2009. A study from the National Joint Registry of England andWalesalso reported in 2010 a high rate of problems with the DePuy implants.

Hip implants usually are effective for 15 years. Within 5 years, the DePuy ASR Resurfacing System had to be replaced in 12% of the patients. Revision Surgery was necessary in 13% of patients with DePuy’s ASR XL Acetabular Hip Replacement.

How many patients may have a defective ASR device?

Worldwide, almost 93,000 patients received DePuy ASR implants. In theUnited States, over 11,000 patients with hip replacements may require surgery to replace the defective device.

What should I do if I want to file a personal injury claim?

If your physician confirms that you have a DePuy ASR hip implant and you have experienced problems, you may qualify for compensation for any pain and suffering, additional surgeries, and cost of care and treatment. If you would like more information about your rights concerning a legal claim, please contact The Cochran Firm – Dothan at 334-673-1555.