Stryker Corp. recalled two of its hip implant systems — the Rejuvenate Modular and ABG II Modular-Neck Hip Stems — in the U.S. in 2012. Now the company faces mounting lawsuits filed by patients who received the recalled hips. Health Canada issued a recall of the Stryker LFIT V40 CoCr Femoral Heads.
The Stryker Corporation, one of the world’s largest manufacturers of medical equipment and orthopaedic devices, issued recalls for some of its hip implants, including the Rejuvenate, ABG II and Accolade TMZF Stem.
It recalled the Rejuvenate Modular and ABG II Modular-Neck Hip Stems in 2012 and stopped all global sales and production of these components. The recall came three months after Stryker issued an “Urgent Field Safety Notice” to surgeons and hospital risk managers pointing out the potential health hazards associated with the two products — including corrosion and “fretting,” which allows minute shards of its metallic components to leach into a patient’s tissues, bones and bloodstream. This could cause a condition known as metallosis, or metal poisoning.
Another hip stem, the Accolade TMZF, also caused problems. The company recalled those models in 2009, 2011 and 2013 because of packaging and manufacturing errors. This hip is made of the same proprietary titanium alloy as the Rejuvenate and ABG II and may corrode and fret when used with cobalt chromium femoral heads.
A number of people claimed they suffered painful side effects like tissue and bone death at the implant site and early device failure. These complications led thousands of plaintiffs and their families to file Stryker lawsuits. In 2014, the device maker settled thousands of lawsuits filed by people who say the Rejuvenate and ABG II injured them.
Why Stryker Recalled Rejuvenate, ABG II and Accolade
Stryker’s official recall announcement, dated July 6, 2012, stated that the company’s decision to “remove Rejuvenate and ABG II stems and terminate global distribution of these products comes after continued post-market surveillance.” The company’s vice president and general manager of hip reconstruction, Stuart Simpson, added: “Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data.”
In the third-quarter of 2012, following this recall, Stryker Corp. reported a 1 percent drop of reconstructive joints overall. Stryker’s international markets turned in the worst performance in the division, with artificial hip sales down 9.6 percent and knee implants down 4.3 percent, according to The Wall Street Journal.
The neck components of the Rejuvenate and ABG II are made of chromium and cobalt, and the stems are coated with titanium. When these parts rub against each other where the neck meets the stem, they can shed metallic debris into the body and lead to complications.
In an Urgent Field Safety Notice issued immediately before the recall, Stryker warned that post-market data revealed that the Rejuvenate and ABG II had an increased rate in Adverse Local Tissue Reaction (ALTR) – meaning complications arising from inflammation in the tissue in and around the implant.
|According to the notice, there are several potential hazards:|
|Fretting and corrosion in and around the modular neck junction can release excessive metal debris into the surrounding tissue.|
|Metal ions in surrounding tissues can result in inflammation leading to an immunological response including metallosis (metal poisoning), necrosis (tissue and bone death) and pain requiring revision surgery.|
|Patients with metal sensitivity may have a severe allergic reaction that requires revision surgery.|
|Excessive metal debris in the joint space can lead to osteolysis, also known as bone loss, and may require revision surgery.|
In addition, some studies suggested links between the absorbed metal ions and neurological and heart problems, as well as damage to the lymph nodes, spleen, liver and kidneys. These studies also considered cobalt especially toxic.
The U.S. Food and Drug Administration received hundreds of complication reports involving the implants in 2012. Experts urge anyone who received these implants to consider having their blood tested for cobalt and chromium levels, whether they suffer from symptoms or not. Cobalt-chromium levels of above 0.3 micrograms per liter (mg/l) or parts per billion (ppb) are considered abnormal and should be monitored for any future complications.
This is not the first time Stryker has recalled a hip implant. In 2008, the company recalled its Trident Acetabular PSL and Trident Hemispherical cups, manufactured at a facility in Ireland.
Stryker LFIT V40 CoCr Femoral Heads
While the FDA or Stryker did not issue a recall for the LFIT V40 CoCr Femoral Heads in the U.S., Health Canada issued a recall on two separate occasions for this device. The first recall came on September 10, 2015. “Stryker has received customer complaints about L.F.I.T V40 Vitallium Femoral Heads (manufactured July 7th 2014 – August 15th 2014). It was reported that the Femoral Head could not be assembled with its corresponding V40 stem trunnion at the time of surgery,” according to the recall.
Health Canada issued a second recall notice on August 24, 2016 because some of the devices failed. “Stryker has received higher than expected complaints of taper lock failure for specific lots of certain sizes of LFIT Anatomic CoCRrV40TM Femoral Heads manufactured prior to 2011,” the recall said.
People who received these devices may suffer the same issues as those from the ABG II and Rejuvenate. The joint where the metal stem and femoral head meet may corrode and release metal ions similar to other metal-on-metal implants. This can cause device failure and metallosis, among other injuries, that may lead to revision surgery.
Broadspire Case Management
Stryker hired Broadspire to gather information and process claims related to the Rejuvenate and ABG II. Broadspire is a third party risk management company that specializes in handling workers compensation, liability and medical case management for large companies. This company’s job is to verify that claimants actually have the recalled devices and to reimburse out-of-pocket expenses for medical treatment related to Stryker’s recalled implants. These expenses might include: doctor visits, blood tests, revision surgery and rehab.
However, Broadspire works for Stryker and may put the device maker’s interests ahead of a patient’s. For instance, any medical information gathered may be used in any future lawsuits and can negatively impact a claimant’s case. The company does not reimburse for emotional distress, disability, suffering or loss of quality of life. If a claimant wishes to deal with Broadspire, it is important to consult an attorney to protect his or her legal rights to any future litigation against Stryker.
Stryker Recalls Lead to Lawsuits
Soon after Stryker issued the recall, a number of people who suffered complications like fractured hips, loss of tissue and bone, as well as debilitating pain filed lawsuits against the device manufacturer.
One of these people is Branko Obradovic. Obradovic filed a lawsuit after his Stryker hip failed soon after it was implanted, and he ended up having revision surgery 15 months after. Now, he can barely stay seated for very long and says just getting out of a car is an ordeal. “I’m very angry about the whole thing,” he told the Palm Beach Post. “They should know what they are putting in someone’s body.”
Lawsuits filed against Stryker allege that the company was negligent in failing to warn the public about the high rate of failure. They also accuse the company of making fraudulent claims that the titanium and cobalt chrome neck and stem in the Rejuvenate and ABG II were resistant to fretting and corroding.