Friday, January 10, 2014

Stryker Continues to Face an Increasing Number of Lawsuits

A total of 607 plaintiffs have now filed a lawsuit against Stryker Corp. over injuries allegedly causes by the company's recalled hip implants. This was reported by the multidistrict court (MCL) court in New Jersey which is overseen by Judge Brian R. Martinotti. The Rejuvenate Modular Hip Stem or ABG II Modular-Neck Hip Stem were recalled by the company in July 2012 due to safety issues.

When the MCL commenced in January 2013, merely 10 plaintiffs filed their cases. The number went up to 382 in September 2013. From that, it increased to 553 in November 2013 giving a total of 171-plaintiff increase (44 percent increase) in just two months.

Similarly, the number of cases in the federal multidistrict litigation (MDL) in Minnesota court also continues to increase.

Thursday, January 9, 2014

Stryker Issues Recall of MoM Hip Devices Due to Design Problems

Stryker Corporation, one of the largest hip manufacturers in the world, has been manufacturing hip replacement systems since before the 90s, online sources say. The first hip systems made by the company were traditional metal-on-plastic and metal-on-ceramic hip devices. In the late 2000s, however, the company started manufacturing hip devices with a metal-on-metal (MoM) design known as the Rejuvenate and ABG II modular-neck hip stems. These implants are supposedly better than other types of hip devices due to their modular design. Unfortunately, the hip systems did not live up to the expectations of many.

The Rejuvenate and ABG II Modular Model

Unlike traditional MoM hip systems, the Rejuvenate and ABG II Modular hips are made up of multiple neck and stem components. Both hip devices were subsequently approved by the U.S. Food and Drug Administration (FDA) in the year 2008 and 2009. The company boasts that, due to the devices’ modular design, orthopedic surgeons are able to custom-fit implant patients according to their anatomy. Moreover, the company also stated that the hip devices are made for younger patients with active lifestyles, able to last for more than 15 years before needing a new replacement.

Initially, the above Stryker hip devices became very popular. However, their popularity gradually declined due to reports of serious Stryker hip complications. These reported complications include metallosis, tissue necrosis, muscle damage, pseudotumors, and cobalt poisoning. Aside from complications, there were reports claiming that affected patients would almost always need hip revision.

Problems associated with Stryker’s hip replacement systems are said to originate from their MoM design. Research studies conducted over the years show that components of such hip devices may shed tiny metal particles in the blood of implant patients during movement. As soon as these particles accumulate, implant patients may potentially develop complications related to metal toxicity.

In addition to filed Stryker hip lawsuits, safety concerns were also raised by federal health regulators. In the end, the company issued a voluntary product recall of the Rejuvenate and ABG II Modular hip devices in July 2012. The recall reportedly sparked numerous lawsuits involving Stryker hip systems, many of which allege negligence.  

fda.gov/safety/recalls/ucm311043.htm
mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con171937.pdf