On August 26, 2010, the DePuy Orthopaedics unit of Johnson & Johnson recalled two types of hip implants. Only one of the recalled products was sold in the United States – The DePuy ASR WL Acetabular System. Earlier this year, the New York Times reported that the FDA has received hundreds of complaints since 2008 from patients experiencing pain and other symptoms that led to revision surgery within the first five years of receiving a DePuy ASR hip implant. New Data indicates that approximately 13% of patients (one in eight) who were implanted with an ASR hip implant were forced to undergo a second hip surgery to remove the defective product. A hip joint is a type of “ball and socket” joint and total hip replacement involves replacing both parts at once. The ASR hip implant system, launched in the U.S. in 2004, is comprised of the ball (or femoral head) which connects to the stem and then fits inside the bowlshaped socket (acetabulum.) With an ASR hip, a concave metal piece is used to provide it a smooth link for the acetabulum. All components of the ASR hip implant are included in the recall. Late last year, DePuy indicated it was phasing out the implants because of slowing sales. However, in March of 2010, the company warned doctors that the implants might have a high failure rate in some patients.
We are seeing problems arising from other similarly designed metal on metal implant devices produced and sold by other manufacturers. It appears that these devices also wear down and produce metallic debris that cause problems for patients similar to those who received the DePuy ASR implant. If similar symptoms develop involving other manufacturers devices, the protocol is the same to make sure that the patient is protected.
If you have not had the hip revised and the ASR implant removed, it is important to monitor your blood, serum and urine for signs of infection or other problems related to the implant. It also may be prudent to consult a surgeon to aspirate Synovial fluid from the affected hip joint. These minimally invasive procedures will allow monitoring of Chromium and Cobalt ion levels to determine the status of the device and if there is an immediate problem. If you are going to undergo a revision surgery to remove the ASR implant, it is critical that certain protocols are followed to preserve the evidence of failure for use in proving the claim on behalf of the patient. Preservation of the affected soft tissues, bones and fluids is critical as is the preservation of the explanted acetabular device and its component parts. We would be more than happy to provide more specific information to any treating physician or facility regarding these critical steps in evaluating the failure or potential failure of the ASR implant or similar device produced by any other manufacturer.
CAUTION:
- DePuy is currently offering a reimbursement plan to patients for expenses related to revision surgeries. We do not advise any client/patient to sign any form of document or release which in any way gives up rights against the manufacturer.
- We also advise against allowing a representative of DePuy or any other manufacturer to attend or observe the surgery or to inspect or take possession of the explanted hip components. It is our opinion that this offer to reimburse expenses is illusory as most costs are covered by insurance or Medicare. More importantly, the program does not compensate the patient for having to undergo surgeries for a failed device.
- It is our advice to all medical professionals not to endorse the reimbursement program or otherwise opine of the benefits of the same.
- “Is my DePuy Hip Implant Defective?”
Contact your surgeon or hospital if you are not sure whether you have the recalled DePuy hip implant. They can determine whether your hip implant is affected by the recall.
“What should I do next?”
While problems caused by the recalled DePuy hip implant could occur at anytime in the future, there is a time limit to file a claim; so it is important to protect your rights now.
Blalock Walters is pleased to provide you the recent information regarding the DePuy Hip Implant Recall.
We thank Mr. Robertson for his contribution. Should you have any questions, please contact me, Jonathan Fleece, Esq. at 941-748-0100 or jfleece@blalockwalters.com
