Louisiana Resident Files Stryker Hip Lawsuit Due to Trident Acetabular Implant

A resident in Louisiana has filed a lawsuit against Stryker Corporation because of the health issues she has been experiencing a year after she had her hip replacement implant. Joann Alcorn, the plaintiff, claimed that the Stryker Trident device was the main reason why she suffered from complications. The lawsuit states that Stryker Corporation owes her more than $75,000 for damages.

In December 11, 2002, Alcorn went through a hip replacement surgery on her left hip, in which the Stryker Trident Acetabular system was implanted. Six years later, the Trident hip replacement system models were pulled out because of the number of complaints the manufacturer and the Food and Drug Administration (FDA) had received. The most common reactions to having the Trident hip implant are difficulty with ambulation, loss of range of motion, and severe hip pain. Alcorn says the pain worsened when she made any movement while in an upright position. Eventually, she ended up in a wheelchair because she could no longer walk.

Recently, Stryker Orthopedics issued another voluntary recall for another model of hip replacement systems. This time, the products recalled are the Rejuvenate and ABG II hip implants. Both were pulled out on July 2012. Both modular-neck implants had a metal neck that was placed inside a metal stem. Over time, these two components would shed small shards of cobalt into the surrounding tissues. The debris also entered the person’s bloodstream, therefore causing metal poisoning (metallosis) and tissue death (necrosis). Severe pain within the implant’s area and bone fractures were also experienced by some patients.

Unlike the Rejuvenate and ABG II, the Stryker Trident had different problems – it was made of ceramic. The Trident hip replacement systems resulted in implant failures, squeaky joints, and bone fractures. Due to all the complexities the Trident caused, patients had to undergo revision surgery much earlier than anticipated. Instead of the estimated 15 years, revision surgery had to take place around the fifth year after the original implantation.

Joann Alcorn stated in the Stryker hip lawsuit that the Trident PSL acetabular shell prematurely loosened. The component failed to merge to the bone as intended. The plaintiff had her hip implant replaced on May 2009, undergoing another surgery. After the first revision surgery on May 2009, she had another one on June 2011. Unfortunately, both surgeries were not successful. To this day, Alcorn still suffers from severe and chronic hip pain.

Alcorn added in the Stryker hip lawsuit that Stryker Corporation failed to conform to manufacturing guidelines mandated by the FDA. During the FDA inspection in a Stryker facility, inspectors found the plant to be contaminated with Staphylococcus. According to Alcorn’s attorney, excess contamination of these bacteria can interfere with the bony ingrowth, which is needed to secure an implant in place.

Stryker Hip Lawsuits Filed Due to Metal Poisoning and Other Adverse Side Effects

In June 2008, the Food and Drug Administration (FDA) approved the Stryker Rejuvenate and ABG II hip systems to be sold in the market. The approval was done by way of its 510(k) process. The Stryker hip replacement devices are created to ease the pain of a person whose hip joints are not working properly due to certain injuries or ailments. Stryker hip devices are also supposed to provide better mobility than other prosthetic hips sold.

Rejuvenate and ABG II Recall

Stryker Orthopedics issued the recall of both Rejuvenate and ABG II modular neck stems on July 5, 2012. The vice president and general manager of Stryker Orthopedics announced the news adding that the potential risks connected to the implant’s corrosion and fretting drove them to stop producing the devices. Patients who have had Rejuvenate or the ABG II received the same adverse side effects than those who have metal-on-metal hip replacements. This is because two of the implant’s parts are created in metal-on-metal design. The Rejuvenate, though, is plastic-on-ceramic.

Health Complexities in Connection with Stryker Hip Implants

Even if the Stryker website states the incidence of complications linked to their modular neck stems are low, patients who have faced health complications due to the prosthetic hip have each filed their own Stryker hip lawsuit.

Patients who went through swelling and pain within the hip area should visit their doctor for a thorough examination. They are also advised to check their own medical records and see the implant’s identification number and to follow the surgeon’s outlined post-operative plan – those who do not have symptoms after the first year are encouraged to do the same.

Cobalt and Chromium in the Body

Many individuals claim that the Rejuvenate modular neck stems produce swelling and severe pain in the hip area. Those who have done research suspect they might have high levels of chromium and cobalt in their body. The release of chromium will allow the white blood cells to absorb it, which will be followed by corrosion and oxidation.

Although the hip system is ceramic-on-metal, the metallic parts may have rubbed against other components which cause tiny shards of metal to be released into the bloodstream. Aside from metal poisoning, another adverse side effect the Stryker hip system can trigger is tissue death known as necrosis.

For several patients, complications due to Stryker’s hip replacement devices have made them lose their jobs. Others go through revision surgery to correct the problem. A number of victims have filed Stryker hip lawsuits because they want to be reimbursed for the medical bills they spent. Aside from that, they want to be recompensed for the damages caused by the hip replacement system.

Stryker Orthopedics Recalls their Latest Hip Systems

Stryker Orthopedics admitted that their Rejuvenate and ABG II hip systems have failed because they caused metallosis in several patients. This resulted to the company recalling both products in the first week of July 2012. Since then, most doctors have informed their patients that the Rejuvenate and ABG II can potentially cause heavy metal poisoning and soft tissue necrosis.

After visiting their doctors, patients now have an idea of what caused months of pain in various parts of the body. They have also complained of pseudotumors, which are tiny sacs of liquid triggered by the body’s immune system in an attempt to block the toxic metals from the hip implants. Other patients also had metal artifact reduction sequence (MARS).  MRI scans have revealed a collection of fluid around the hip joint.

Doctors have told their patients that they are in need of revision surgery to fix the medical problems they acquired. The patients question the credibility of the Stryker hip implants since they weren’t supposed to have revision surgery until 10 to 15 years after its installation. In the case of the Stryker hip replacement device, many negative side effects happened after a year. Many patients ended up paying a large amount of money to fix the medical problem which includes rehabilitation. A number of these patients are still paying for the first surgery on a monthly basis and want to file a Stryker hip lawsuit in order to compensate for all their losses.

In some cases, doctors recommend that their patients have surgery since they are in pain and the implant is poisoning them. The sad thing is, the patients cannot afford to have the defective hip removed. Concerned doctors and lawyers have urged Stryker Orthopedics to put forth objective claims in place. This will assure victims who filed Stryker hip lawsuits that their lost wages and medical expenses will be reimbursed if they go through the surgery to have the defective hip implant removed. Stryker has still not mentioned anything about the damages their hip replacement systems have caused.

A lot of doctors have informed their patients that their health complications may be irreversible the longer the hip stays within their system. Metal-on-metal hip replacement devices are also known to cause damage to tissues around the person’s hip to the point of necrosis or tissue death. The longer it takes for the patient to have revision surgery, the more risky it is to remove the stem.

Product Recall of ABG II and Rejuvenate Too Late for Stryker

During the first week of August 2012, a 66-year old woman from Florida filed a Stryker hip replacement lawsuit in the Bergen County superior court. She sought compensation for the defective Rejuvenate hip replacement components which gave her a number of serious health complications. The plaintiff underwent hip replacement on her right hip in October 2011. Months after the surgery, she felt severe pain and her blood samples showed she had high levels of metal caused by the Stryker Rejuvenate modular hip system. In June 2012, her doctor advised her to undergo revision surgery to remove the abnormal tissue growth near her right hip. The plaintiff needs more surgeries to correct her health problems.

On July 2012, Stryker recalled its ABG II neck stems and Rejuvenate Modular hip implant stems. The reason for its market recall was stated as “potential fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.” Stryker Orthopedics leads the worldwide market for hip replacement parts, but patients implanted with the metal hip systems have been diagnosed with metallosis or metal poisoning. Many experienced a sharp rise in cobalt and chromium levels. Cobalt and chromium is what makes up the Rejuvenate modular hip implant. Aside from the cobalt and chromium stem, the neck is made of titanium. The FDA received 60 complaints against Stryker’s Rejuvenate modular hip implant from January to July 2012.

The metal parts of the Rejuvenate implant rub against each other when a person does normal day-to-day activities. The hip implant’s defective design is the main reason of metallosis and the devices’ failure. Aside from metal poisoning, complaints on the Rejuvenate hip device include infection, bone necrosis, pseudotumor formation, and abnormal tissue formation. The most highlighted drawback of the Stryker Rejuvenate hip device is that the company never conducted safety trials on the product before its introduction in February 2010. Stryker Orthopedics sought the FDA’s approval through the agency’s 510(k) clearance program. The program approves any product that has a substantial equivalent sold in the market and the Rejuvenate and ABG II were said to be akin to the Wright Profemur hip implants.

The FDA warned Stryker Orthopedics about their devices twice. In November 2007, a FDA team visited a Stryker facility in New Jersey and discovered clusters of Staphylococcus bacteria throughout the plant. Before the Rejuvenate and ABG II neck stems were manufactured, Stryker had already pulled out two products in 2008: the Trident Hemispherical and Acetabular PSL Cups.  Unfortunately, when the company recalled their products, several patients have already filed their respective Stryker hip replacement lawsuit. According to Forbes, manufacturers of metal hip implants may cost an estimated $5 billion with 30,000 lawsuits in the coming years.