Urgent Recall: Informational Notice Regarding Bad Hip Implants, Patients Should be Wary of DePuy's Promises for Reimbursement

The following recall notice was released relating to the defective hip replacement implants manufacturered by DePuy, subsidiary company of Johnson & Johnson. If you or someone you care about may have been a patient who had hip replacement surgery and suspect the implant might by of the DePuy company, you should immediately contact Gray and White Law with any questions or concerns you may have to speak with an experienced and knowledgeable attorney who specializes in claims for injuries relating to medical device implants by dialing toll-free at 1-800-634-8767 or by confidential e-mail.

URGENT INFORMATION – RECALL NOTICE
ASRTM XL Acetabular System/DePuy ASRTM Hip Resurfacing System

Dear Clinicians:

As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the UK that demonstrated the ASRTM System had a higher than expected revision rate at 8-9 percent at three years when used with smaller head sizes (less than 50 mm diameter). The overall revision rate for ASR continued to be in line with the class of metal-on-metal monoblock systems based on the data available to DePuy at that time.

DePuy has just received new, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales. The data shows the five year revision rate for the ASRTM Hip Resurfacing System is approximately 12 percent and for the ASRTM XL Acetabular System is approximately 13 percent. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients. Because the new NJR data shows a higher than expected revision rate at five years, DePuy is issuing a voluntary recall of all ASR products.

Reasons for revision identified within the datasets are consistent with those previously reported for ASR and include component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain.

Note: The DePuy ASRTM Hip Resurfacing System was only approved for use outside the U.S. and the ASRTM XL Acetabular System was available worldwide.

Please share this notice with your organization and any organization where the ASR products may have been transferred. Do not implant the ASR devices. Your DePuy representative will assist with returns of any remaining inventory.

Patient Follow Up
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit. Patients with radiographic changes indicative of product failure should be addressed according to normal procedures. All other patients should be followed according to the April 22, 2010 and the May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.1, 2 Per the April 22, 2010 Device Alert, a small number of patients may develop progressive soft tissue reactions to metal wear debris. The debris can cause soft tissue damage which may compromise the results of the revision surgery. Early revision of poorly performing hip replacements that generate metal debris should give a better revision outcome. Therefore metal ion testing should be considered in cases where the surgeon is concerned about the hip replacement. The May 25, 2010 Alert specifies the following actions specific to the ASR:

    •    Follow up all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.

    •    For patients who are symptomatic or implanted with a cup angle greater than 45°, particularly where a small component has been implanted:

    •    Consider measuring cobalt and chromium ion levels in whole blood and/or performing cross sectional imaging including MRI or ultrasound scans

    •    If meta lion levels in whole blood are elevated above7parts per billion(ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging

    •    If MRI or ultrasound scan reveals soft tissue reactions,fluid collections or tissue masses, then revision surgery should be considered.

Financial Support for Patient Follow Up
DePuy intends to cover reasonable and customary costs of monitoring and treatment for services, including revisions, associated with the recall of ASR. Diagnostic testing, as recommended by the MHRA, may be used when surgeons have concerns about a patient with the ASR System. The procedure for the reimbursement process will be provided to you at a later date, but fees for services should first be submitted to payors in the usual manner and DePuy will then reimburse patients and payors for out of pocket reasonable and customary expenses.

Reimbursement is subject to the completion and submission of required documentation to DePuy to confirm eligibility. Eligibility will be determined, in part, by validation that the patient has an ASR component implanted and has consented to provide DePuy with x-rays, explants and any other requested medical information after the revision surgery. Further details and procedures regarding this guidance will be provided in the near future.

Sincerely,
Pamela L. Plouhar, Ph.D. VP,
Worldwide Clinical Affairs

Lawsuits have been filed against Johnson & Johnson and DePuy for claims of injuries and allegations that DePuy is misleading or deceiving patients regarding its offer to reimburse or provide revision surgery, that is, the company will consider your case only after you sign away your rights and sign their medical release and/or will use your medical records for purposes of strengthening their defense against the oncoming increasing number of individual lawsuits and class action litigation. Please do not contact DePuy without first consulting with, and obtaining information from, the attorneys of Gray and White Law - who you can trust to represent your rights and help recover you and your family for losses. We can be reached at any time convenient for you, simply contact Gray and White Law for a free legal consultation by sending a confidential e-mail or by calling us toll-free at 1-800-634-8767.