Most patients who have hip replacement surgery expect to have a new lease on life, with increased mobility and reduction in pain. Doctors and patients alike must trust the hip implant manufacturer to make and sell only devices that are safe and effective. Unfortunately, we’ve seen a host of hip recalls over the past ten years. What’s worse is that most patients have no idea whether or not the hip replacement they had is part of a recall.
When it becomes clear a hip replacement device is malfunctioning, not only can it cause the patient physical pain and infection, but also decrease mobility even more.
Thousands of patients have reported experiencing severe pain, swelling, and physical difficulty caused by hip implants.
In July of 2012, Stryker recalled the particular hip system that includes both the Rejuvenate Modular and ABG II modular-neck hip stems. These systems, along with other metal-on-metal hip replacement systems, have been linked to need for premature revision surgery, significant damage to the soft tissues, infections, soreness, squeaking joints, and other health issues.
In May of 2006, Smith & Nephew introduced the Birmingham Hip Resurfacing (BHR) through the Premarket Approval (“PMA”) process. A typical total hip replacement system consists of four separate components: 1) a femoral stem; 2) a femoral head; 3) a liner; and 4) an acetabular shell.
The Smith & Nephew BHR can be used in a resurfacing procedure or may be combined with a femoral stem in a total hip replacement.
Zimmer has initiated a voluntary recall some of its M/L Taper with Kinectiv Technology Femoral Stems and Necks used in hip replacements.
The recall, which Zimmer is calling a “process monitoring failure,” is due to higher than expected amounts of manufacturing residues left on the devices. The FDA is categorizing this as Class 1, the most serious type of recall. These residues can cause serious adverse health issues including allergic reactions, pain, infection, or death. Use of these products may require the need for a revision surgery to replace the affected implant.
Smith & Nephew initiated voluntary recalls of certain R3 Hips (those including metal liners), as well as certain Birmingham Hip Resurfacing hips. Contact Meshbesher & Spence to learn more about whether these recalls have impacted you.
DePuy, a subsidiary of the Johnson & Johnson company, recalled it’s DePuy ASR XL line of hip replacement products in August of 2010. There have been a handful of trials, and two “rounds” of settlements for patients impacted by these devices. Attorneys at Meshbesher & Spence have been actively representing patients harmed by these devices for nearly seven years now. Contact us to see how we may be able to help you as well.
While these hips are not subject to a formal “recall”, in early 2013 the FDA revoked the “510(k) Clearance” for all so-called “metal-on-metal” hip replacements. Many patients who had these devices have experienced premature product failure, elevated metal levels in their blood, and early and painful revision surgery.