The Stryker Corporation markets 57,000 products worldwide and generated more than $8 billion in annual sales in 2012. The Michigan-based company is ranked No. 308 on the list of Fortune 500 companies and is valued at more than $20 billion.
The company remained largely unscathed by the controversy over all-metal hip devices made by competitors like Johnson & Johnson, whose DePuy ASR implant is the focus of more than 10,000 lawsuits. In fact, because Stryker does not make all-metal hips, it picked up market share after other companies that made the problem hips saw a huge drop in revenue.
Rejuvenate & ABG II Modular-Neck Hip Stem systems
However, two of its most recent innovations – the Rejuvenate and ABG II Modular-Neck Hip Stem systems, both released in 2009 – have been a source of growing legal troubles for the device manufacturer. These two models were recalled by Stryker in July 2012, after complaints from some of the thousands of patients who have had the products implanted.
Unlike typical hip implant systems, which include a one-piece neck and stem called a monoblock design, Stryker's Rejuvenate and ABG II systems include several neck and stem components. These modular, interchangeable systems were designed to give surgeons greater flexibility by offering them more anatomically correct implant components that could be custom-fitted to patients.
The ABG II system has eight right stems, eight left stems and 10 modular necks, which are supposed to offer greater stability and minimal bone stress. The Rejuvenate hip, with six stems and 16 necks, was marketed to younger patients who were promised longer-lasting devices that offered a better range of motion. The stems are manufactured using Stryker's proprietary titanium alloy blend that mixes titanium, molybdenum, zirconium and iron. The company claimed that its patented blend resisted the effects of corrosion and fretting – small particles of metal flaking off the implant into the body.
Unfortunately, post-market data revealed evidence of corrosion and fretting after the devices were implanted, and Stryker recalled the two systems. The recall came too late for some patients. The devices caused serious side effects, including loosening of the implant and the release of toxic metals into patients – complications that are leading to a number of lawsuits against Stryker.
On July 22, 2009, the U.S. Food and Drug Administration (FDA) announced that Stryker Corporation had recalled its Accolade TMZF hip stem.
What Is the Stryker Accolade TMZF Hip Stem?
The Stryker Accolade TMZF is the stem portion in a total hip replacement system. In this procedure, hip stems are inserted into the thigh bone to provide support to a femoral head or "cup" which is used as a pivot between your leg and your hip. This may be used in either an initial implantation procedure or a revision procedure. The Accolade TMZF is comprised of mostly titanium, unlike most stems, which are often made of cobalt and chromium.
The FDA announced that the Accolade TMZF hip stem constituted a class II recall. According to the FDA, Stryker recalled specific lots of the device because they deviated from Stryker's specifications for "tensile bond strength and crystallinity." This could lead to particles in the metal coating of the stem to release into the body, which increases the risk for osteolysis, or weakening of the bone, which can cause the hip stem to loosen over time.
When Osteolysis occurs, the femur bone may weaken and the hip implant may wobble within the bone. Patients with Osteolysis will experience pain, limitations in range of motion, and possibly hear squeak-like noises.
If the condition becomes severe, osteolysis patients may have to undergo surgery to correct the problem, which may require that the stem be removed.
The recall affects 1,628 hip stems. The FDA defines a class II recall as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
If you or a loved one underwent hip replacement surgery and had one of the recalled Stryker hip stem devices implanted, you may be able to seek compensation for your injury, pain and suffering, and help with medical bills and other expenses.
Call Dean Goetz at 858-481-8844 or send email to email@example.com today and speak to Dean directly.
Metal on Metal Hip Device Recall - Depuy
Dean A. Goetz and the Gomez Law Firm were the attorneys for Mr. Loren Kranksy, the Plaintiff in the first Depuy trial in the USA. 3/6/13 at 9:38 a.m. PST A jury found Depuy liable to Mr. Loren Bill Kransky today in a Los Angeles Superior Court. FIRST verdict in the USA against Depuy for $8,328,000. We Are The Kransky Lawyers
Kranksy vs. Depuy and Johnson and Johnson, Los Angeles County Superior Court Case #BC456086
The Walking Wounded - Dean Goetz interviewed ABC Investigative Report - watch the whole investigative story on Depuy, aired 5/26/14, "Reporter Quentin McDermott reveals how a healthcare giant deceived doctors and patients using its ASR hip replacement implant." Australian class action cases go to trial in 2015.