DePuy ASR & Pinnacle Hip Implants Attorneys
The attorneys at Robinson Calcagnie, Inc. are currently investigating claims of people who are experiencing hip pain, immobility, or have had to undergo additional hip surgery due to the failure of the following DePuy hip implants: the DePuy ASR XL Acetabular System and the ASR Hip Resurfacing System.
Recent data shows that one in every eight (13 percent) ASR hip implants over a five-year period required replacement surgery. This revision rate is much higher than normal or anticipated.1
Some of the reported side effects include:
- Implanted cup loosening or failure to bond to bone
- Bone fracture
- Dislocation of the implant where the two parts of the implant are no longer aligned
- Pseudotumor: a soft tissue mass that may be the result of a toxic reaction to metal particles/metal wear debris
- ALVAL (Aseptic Lumphocyte Dominated Vasculitis Associated Lesion) an adverse tissue reaction to metal particles and ions
DePuy Implant Recalls
The DePuy implants subject to an FDA Class II Recall/Field Safety Notice effective July 17, 2010, and recalled by the manufacturer on August 24, 2010, are as follows:
- ASR XL Acetabular System, a hip socket used in traditional hip replacement
- ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur, a method intended to preserve more bone
The DePuy ASR XL was a hip replacement system that was initially approved by the FDA in 2005, although it was available outside the U.S. beginning in 2003. The DePuy hip resurfacing system is a metal-on-metal, ball-and-socket hip prosthesis used in hip replacement surgery. DePuy touted the implants as a “high performance” replacement system claiming significant advantage over other more conventional implants. However, the ASR hip implant did not live up to DePuy’s representations. In fact, the FDA has received over 300 complaints from patients or their doctors about the DePuy hip system since 2008. DuPuy acknowledged in its April 22, 2010, Device Alert that the metal-on-metal contact of the ASR system can create metal debris that can result in inflammation and other soft tissue reactions, and may result in damage to nearby muscle and soft tissue compromising the results of the revision surgery.1
Premature failure of a hip implant can result in significant physical, emotional and financial hardships. Lawsuits against DePuy are beginning to be filed around the country. These lawsuits assert that the DePuy hip implant system was defective and that DePuy knew of the increased potential for failure.
If you have had a hip replacement since 2003 and are experiencing pain or were required to undergo another replacement, check with your physician or hospital to determine if you had a DePuy ASR hip implant used. If you or a loved one have been harmed by DePuy’s delay to announce the problems with the DePuy Hip Implant, contact our attorneys for a free case evaluation to find out more about your legal rights and options.
FDA Warns J&J’s DePuy Orthopaedics Unit on Product Marketing Violations
The AP (8/25, Johnson) reports that the Food and Drug Administration has warned Johnson & Johnson’s DePuy Orthopaedics, Inc. unit that “it is illegally marketing two products,” one which “was never approved for sale, and that it is selling another product for uses that have not been specifically approved.” In its Aug. 19 letter to the company, the FDA wrote that “DePuy is marketing its Corail Hip System for two unapproved uses, and promoting those uses in an online brochure.”
1 DePuy Orthopaedics Inc. Dear Clinicians Letter August 24, 2010.