Knee and Hip Replacement Problems Will Be Identified Sooner in U.S. With New Registries
Two new knee and hip implant registries have recently launched in the United States, which will track reports of hip and knee replacement problems. This will help healthcare professionals and consumers obtain better information when deciding between different options, and will also help prevent manufacturers from delaying recalls for defective products.
The American Joint Replacement Registry (AJRR) began tracking problems with knee and hip replacements in December at 16 hospitals and is expected to begin operating on a nationwide basis later this year. Another registry based out of the University of Massachusetts (UMASS) Medical School is a much smaller registry that will focus on collecting a wealth of data from each recipient registered.
The AJRR is funded by the American Academy of Orthopaedic Surgeons and AdvaMed, which represents medical device manufacturers. It will focus on monitoring the rates of revision surgery and failure rates for knee and hip replacement implants for all of the estimated 700,000 surgeries that occur each year in the United States.
The UMASS registry is funded through a grant from the U.S. Department of Health Care and Human Services’ Agency for Health Care Research and Quality. It will closely monitor about 30,000 hip and knee implant recipients and will gather in-depth information each individual patient’s experiences with the implant. The registry will quantify the pain felt by the recipient before and after surgery, for example, in addition to revision and failure rates.
The registries are similar to others already in place around the world, like in Australia and the United Kingdom, and sprang into place following a number of high-profile hip replacement recalls issued in recent years and growing concerns about how some manufacturers have responded to potential problems identified with their hip and knee replacement systems.
In August 2010, a DePuy ASR hip implant recall was issued for about 93,000 artificial hips after the manufacturer confirmed that post-marketing data showed that about 12% to 13% of the individuals who received the hip implant had their device fail within five years. The DePuy ASR failure rate was identified through the U.K. implant registry, but some doctors in the U.S. had been voicing complaints about potential problems with the hip replacement system for months before the recall.
Our law firm began investigating potential DePuy ASR hip lawsuits almost six months before the recall was issued, due to a number of complaints involving early loosening and reports that suggested the design of the device may make it prone to early failure. Despite access to information that should have led to an earlier recall, DePuy Orthopadics largely dismissed concerns raised about problems with DePuy ASR hip replacements.
Similar concerns have surfaced in recent months surrounding another metal-on-metal hip replacement manufactured by DePuy, the Pinnacle hip system. A growing number of DePuy Pinnacle hip lawsuits have been filed by individuals who experienced early failure and the FDA has received hundreds of reports of problems with DePuy Pinnacle hip systems.
Because there have not been any registries in place in the United States, there has not been any publicly available data on the DePuy Pinnacle failure rate in the United States. However, the large number of complaints and substantial design similarities to the ASR hip have led to calls for a DePuy Pinnacle hip recall to be issued. If these registries had been in place before this year, it is possible that the a number of individuals throughout the United States who are now experiencing problems would not have received the Pinnacle metal-on-metal hip system.
Without registry information available to the medical community and the public, medical device manufacturers have a substantial incentive to ignore potential problems and turn a blind eye to reports of issues with their implants. In recent years, when experienced surgeons have spoken out about concerns, the manufacturers have been able to downplay those problems or suggest that the issues were limited to a small group of doctors.
In March 2010, a group of orthopaedic surgeons released a report highlighting a potential risk of problems with certain Zimmer NexGen knee replacement systems. At least one of the surgeons was a prior consultant for Zimmer, yet the company dismissed those concerns and suggested that the high rate of problems found were caused by the surgical technique used. The company now faces a number of Zimmer NexGen knee replacement lawsuits, and they have issued several recalls for Zimmer NexGen knee systems.
Zimmer received similar reports of problems with their Zimmer Durom Cup hip replacement system in 2007, and dismissed concerns raised by doctors before ultimately issuing a Zimmer Durom Cup recall in July 2008.
In August 2010, Sen. Charles E. Grassley wrote a letter to the Zimmer CEO and President asking the company for details on how it responded to safety concerns and whether more consultants had raised concerns about Zimmer implants.
There is no good reason not to have a registry to track the successes and failures of hip and knee replacement systems in the United States, and it is good to see that the device manufacturers’ control over the flow of information about potential problems with these medical devices may finally be weakening.
KNEE AND HIP REPLACEMENT LAWYERS
The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential claims for problems with a number of different knee and hip replacement systems, including the Zimmer NexGen knee, Zimmer Durom Cup hip, Wright Profemur hip, DePuy ASR hip, DePuy Pinnacle hip and other metal-on-metal hip replacement products.
To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.