Stryker Side Effect Reports Trigger Lawsuit in Florida

Stryker's Rejuvenate and ABG II hip replacement systems were supposedly designed to last for more than a decade. However, shortly after its release, reports of problems with the hip devices started to arise. As a result, the company issued a voluntary product recall of its modular hip devices on July 06, 2012. Unfortunately, months before the recall was issued, many implant patients were reportedly injured by the faulty hip devices.  

Consequently, one of the implant patients (who received a faulty hip device before the recall) filed a lawsuit against the manufacturer. The plaintiff, Cheryl Riley, filed the lawsuit on December 06, 2012 in the District Court for the Southern District of Florida. According to her, the recall came too late. She suffered from serious complications that resulted in several hip revision surgeries. Her implant was removed.

Stryker's Recall Came Too Late, Injuring Plaintiff and Several Others

Stryker Orthopedics issued the voluntary recall after acknowledging that the modular necks on the hip replacement systems are prone to corrosion, which may cause damage to the surrounding bone and tissue. As a result, hip failure may occur.

According to Riley, Stryker Orthopedics did not warn consumers in time regarding the design defect. She accused the company of negligence, failure to set up good marketing practices, fraudulent deceit, and breach of warranty. Riley and several other implant patients suffered severe complications associated with the hip devices.

The metal components of the Stryker rejuvenate modular hip device have been a lingering issue for the company. Because they scrape against each other, metal fragments are released in the blood of patients. Accumulation of these metal shards may lead to metallosis, a medical condition that may cause tissue necrosis, pseudo-tumors, and bone loss.

Stryker Hip Complications Suffered Before Stryker Lawsuit Was Filed

Riley stated that she had her hip replacement surgery in November 2011. She was implanted with the Stryker Rejuvenate modular hip replacement device. According to her, she started experiencing complications after the neck stem of her hip device suddenly deteriorated. She suffered excruciating pain that led to several revision surgeries. In the end, the faulty hip device was removed.

After all the suffering she went through, Riley filed a Stryker hip lawsuit. She sought compensatory damages for all the distress and pains she suffered. According to personal injury lawyers, patients who are injured by faulty medical devices may approach their lawyers for assistance. Their websites, including the Rottenstein Law Group's rotlaw.com, contain various information regarding lawsuits against Stryker and other metal-metal hip manufacturers.

Stryker Orthodpaedics Facing Multiple Lawsuits Related To Its Problematic Hip Devices

Based on the United States Food and Drug Administration web page, Stryker Orthopedics has recalled two of its hip replacement systems due to their problematic neck stems. According to several reports, implant patients have suffered from pain, tissue inflammation, and other complications. Moreover, the company's Trident hip replacement system has also been linked to several complications.

The Rejuvenate And ABG II Hip Replacement Systems

Stryker Orthopaedics, a manufacturer of orthopedic equipments based in Michigan, recently stated it has discontinued world-wide distribution of the Rejuvenate and ABG II hip systems. The company also stated that patients who experience complications should seek their physicians for check up. According to a statement released by the Managing director of hip reconstruction and also the Vice President of Stryker Orthopaedics, Stuart Simpson, “While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action.”

According to Simpson, the company intends to cooperate with the medical community to further analyze the problems of the hip implants. Furthermore, the U.S. Food and Drug Administration stated that it has received over 40 complaints concerning the Rejuvenate and ABG II hip implants since early 2012. Also, several patients have already filed stryker hip replacement lawsuits.

Interestingly, lawsuits against metal on metal hip systems, such as the Stryker hip replacement systems, are piling up fast. According to a personal injury law firm website, the Rottenstein Law Group's rotlaw.com, “Metal-on-metal hip implants have been the subject of regulators’ concerns recently. In fact, in June 2012, the U.S. Food and Drug Administration convened a special meeting that involved enlisting an 18-member panel to recommend guidelines for monitoring the more than half a million U.S. patients with metal-on-metal hip replacements.” Moreover, information on lawsuits against the manufacturer of the Rejuvenate and ABG II hip systems can be found on this website.

The Stryker Trident Hip Replacement System

The Trident hip replacement device, Stryker's ceramic hip system, is also facing multiple lawsuits. The plaintiffs claimed that the company failed to properly inform patients regarding the risks involved in using the hip device. Apparently, according to reports, the implant patients suffered difficulties in walking, avascular necrosis, and other complications. Stryker issued a recall of two Trident hip components in January 2007.

Unfortunately, according to the Rottenstein Law Group, “After the recall, Stryker faced a number of lawsuits, many of which were consolidated into a class action. The plaintiffs were not able to get any compensation from Stryker, however. The U.S. Court of Appeals for the Fifth Circuit held that, according to a recent Supreme Court ruling, any medical devices approved by the FDA, but not fast-tracked through the 501(k) approval process – which requires no premarket testing – are exempt from product liability lawsuits.”

Ex-spokesperson Joins Class Action Suit Against Hip Manufacturer

A former gymnast claimed that she has suffered severe pain due to her failed hip implant. Penny Brown, the 51 year old ex-gymnast, is in the process of filing a hip replacement lawsuit. Ironically, Brown was the spokesperson of the hip replacement device that has now failed her.

She used to encourage other people to get the hip implant. However, this time she joined hundreds of other individuals in filing a representative action against Depuy Orthopaedics, a subsidiary of Johnson & Johnson.

Penny Brown was advised to undergo revision surgery due to corrosion of the implant. Presently, she is recovering from the invasive surgical operation. She said in a statement, “I could not believe that I, who had so promoted and believed in the product, was falling victim to the design defect. The pain gradually became worse and worse and I was eventually told this year that I would need a revision as a result of the premature wearing caused by the ASR component. I cannot sit or stand for long periods and I’m a shadow of my former self, I’m no longer the hard working, vivacious woman I used to be and would still be if I had not had this implant. I’m extremely angry. As the poster lady for DePuy I’ve not only been let down personally but, as I encouraged others to have it, feel to some extent responsible for their suffering.” She continued, “I was due to have an ASR component for resurfacing of the left hip but the wrong size was delivered so I had to have a Birmingham hip implant instead. A few months later I had the other hip done with the ASA implant, which was heralded as leading technology allowing young patients to return to an active life, which I craved. I was told it would see me through well into retirement and reduce the likelihood of requiring further surgery during my lifetime. I was so pleased with the immediate results of the operations that I agreed to become the DePuy ‘poster lady’. I was included in all the promotional literature and taken to Monte Carlo to launch the product on stage, telling how the ASR transformed my life. I was the DePuys worldwide patient brand and my image was used extensively around the world over a five year period until 2008. Shortly afterwards I started to experience groin pain and a clunking sensation when walking – and then I discovered the product was being recalled. I’m terrified of ending up in a wheelchair. My entire life is on hold, I was offered a top job but had to turn it down because I need revision surgery and I don’t know how it will go. But I’ve never had a minute’s trouble from the Birmingham hip – if only I’d had it on both sides.”

The ASR hip replacement system has a high failure rate. According to reports, the implant's failure rate is double of what was previously anticipated. Based on the merged registry of Wales and England, more than 10% of ASR hip implant patients needed revision surgery after five years. As a result, more than a thousand implant patients were advised to meet with their physicians regularly for check ups.

Several personal injury law firms, such as the Rottenstein Law Group, have been helping injured patients with their cases. These law firms have created websites, such as the Rottenstein Law Group's rotlaw.com, to help monitor the status of lawsuits against the manufacturers of hip systems.

The Misfortunes Of Having A Metal On Metal Hip Replacement System

In 2009, a 57 year old patient named Susy Mansfield required a replacement hip. Thus, her doctor recommended a new and untried hip replacement device. Additionally, the hip device was all-metal. “He said, 'You're young. Metal is good for younger people. It's going to last a lot longer," recalled Mansfield.

In contrast to metal on metal hips, traditional synthetic hips are normally made of hard plastic and metal. These artificial hips are known to deteriorate after ten to fifteen years, particularly in individuals who have active lifestyles like Susy Mansfield. She has a recycling business and likes engaging in outdoor activities, such as kayak, hiking, and windsurfing.

Manufacturers of metal on metal hip replacement systems believe that an all-metal hip meant greater durability. They have designed these hips specially for younger patients who are more active. Unfortunately, all-metal hips were not the right choice for Mansfield and thousands of other hip replacement patients.

Not long ago, Mansfield was in an operating room at a general hospital in Boston, Massachusetts. She had been undergoing revision surgery to get rid of the metal on metal hip device implanted on her more than 3 years past. The device corroded and damaged the tissues and bones around it.  

Before undergoing hip revision surgery, Mansfield suffered from chronic pain that got worse. “It's terrible,” she admitted a couple of days before the surgery. And then she added, “It's a hot pain ... that's there all the time. Every step is agony.” She had to take pain pills in order to sleep.

Later on, Mansfield discovered that the metallic hip she had before the revision surgery was one of the recalled hips of Depuy Orthopaedics, a division of the manufacturing giant Johnson & Johnson. She said that she only saw the recall announcement a year after reading a newspaper article about complications related to the artificial hips.

Metal on metal hip systems became popular during the time of Mansfield's first hip replacement surgery, more than 30% of hip replacement patients had chosen to get all-metal hip devices. During that time, over 70,000 hip replacement surgeries involving all-metal hips were done every year. However, the all-metal hips have declined in popularity since then. In fact, many patients have already filed hip replacement lawsuits.

According to Dr. Joshua Jacobs, the head of orthopedics at Rush University Medical Center in Chicago, metal on metal hip devices have intolerably high failure rates. For this reason, over 5,000 hip replacement patients have filed lawsuits against all-metal hip device manufacturers. The process of filing these types of lawsuits may be confusing, fortunately, there are many dependable law firms to choose from.

According to consumer injury lawyers at the Rottenstein Law Group, “getting satisfaction from the company that harmed you shouldn’t be just more hardship. That’s why we do everything we can to streamline the process.“ Their website rotlaw.com contains valuable information on hip replacement cases.

Failure Rate of Metal Hip Replacements Alarms Canada

Hip replacements made only of metal supposedly last longer than normal hip implants, but recently, another manufacturer recalled a liner used in metallic hips. A British-based company, Smith & Nephew, announced that the clinical results of metallic hips were unsatisfactory. It was one among four companies to have issued a recall since the mid-2000 debut of metal-on-metal hip replacements.

The U.S. Food and Drug Administration intends to review the hip implant to determine how safe the device is for patients. In comparison to the standard metal-and-plastic hip devices, studies show that metal-on-metal hip replacements have a higher failure rate and are more likely to damage tissues around the joint. Therefore, Complaints against the manufacturers of metallic hip implants are growing.

Health And Consumer Organizations Remain Skeptical

Even after the approval of metal-on-metal hip devices, government and consumer organizations remain in doubt. Health Canada published a safety announcement in April, warning people that the device may come loose, cause pain, and damage tissues. The agency pointed out that patients who experience pain and have damaged tissues showing on the MRI must have the implants removed immediately.

Meanwhile, the FDA voiced its concerns on metallic hip replacements, warning patients that friction between the metal components of the device may release small metal particles that could damage surrounding tissues. Moreover, the FDA states that particles might enter the bloodstream and cause metal poisoning.

Effects On Canada

Thousands of Canadians were implanted with the metal-on-metal replacement hip devices. Some had their implants removed while others are allegedly having problems with their metallic hip replacements.

Frank Cristo, a man who underwent implant surgery a few years ago, mentioned that he experienced escalating pain. Thus, he decided to have his metal-on-metal hips replaced. “I was told metal-on-metal was supposed to be the best,” he said. “I was good for the first month or so then I started feeling pain all the time.”

One in every one hundred patients who has metal-on-metal hips develops swelling and pain. According to a research in Canada, a few patients developed tumor-like lesions that seriously damaged their muscles and tissues. Some patients may have filed hip replacement lawsuits for the damages they have suffered.

Doubt On Health Authorities

A study shows that two out of twenty two metal hips implanted in Canadian patients failed. The person who helped organize the study and is also the previous president of the Canadian Orthopaedic Association, Dr. Ross Leighton, assumes that the metal-on-metal hip replacements were not thoroughly studied before its approval.

Man Lives In Agony for Having Stryker Rejuvenate Hip

A man is living in agony of pain and discomfort following a surgery involving a Stryker hip replacement. Mr. Ewell lamented the fact that “The pain started immediately after surgery.” He also related that he went back to his surgeon thrice within a year, been subjected to multiple x-rays, as he believes that the pain was caused by scarred tissue resulting from surgery.   He thought that it would just go away after awhile but never did. There is an indication that Mr. Ewell might be experiencing more than just ‘scar tissue’.

The 65 years old man further lamented, “My hip hurts more now than before I had the Stryker replacement.” He added, “I’m retired and trying to build a new house—I have more time than money since retiring—but this hip is really slowing me down. Nine years later, I can’t lift anything more than about 30 pounds.”

Presently, the poor man believes that his replacement hip is one of the recalled items falling under Stryker Orthopedics Rejuvenate Modular Hip System Recall. Since the recall has been issued on Rejuvenate Modular Hip System and ABG II Modular-Neck stems in July 2012, individuals have filed a Stryker hip lawsuit against the manufacturer.  And the number of lawsuits filed by those affected and suffering the injuries wrought by the hip replacement is continuously increasing. Ewell, on his part, worries that the pain may now be the symptom of metallosis.  The condition is the body’s response to heavy metals involving adverse tissue reaction.

There is a rising number of conclusive evidence that metal-on-metal hips are dangerously defective.  This resulted in thousands of lawsuits being filed by people who are suffering from metallosis, muscle damage, and total failure in their hip replacement.

It must be noted that, although the Stryker Rejuvenate is not a metal-on-metal hip device, the neck component is made of metal. And in some instances, the piece reportedly rubs against the metal stem, causing metallic debris to loosen up, which in turn leads to metallosis.

The Serious Health Problems Related With Stryker Rejuvenate & ABG II Hip Systems

The two hip replacement system product recall ordered by Stryker in July 2012 was due to the adverse health issues caused by the metal parts included in the hip system device. Rejuvenate and ABG II modular-neck hip stem systems are the two device being ordered for recall. Stryker Corporation will also cease the production and distribution of the two hip implant systems.

These devices have similar reported side effects in using metal-on-metal degradation, metal poisoning and failed implant of the hip system. Many recall orders for metal-on-metal hip implants are already being implemented.

As reflected on the recall’s information ordered by Stryker, the post-sale evaluation implied that the dismissed devices are possibly apt for metal component deterioration. Specifically, the wearing out of the modular – neck stem can result to implant sore, muscle swelling and other serious complications.

Most hip implant systems have a one-piece design involving the femoral neck and stem. The Stryker Rejuvenate and ABG II on the other hand are designed with detachable neck and stem metal components made of chromium, cobalt, and titanium alloy.

As these two metal components rub each other every time a person moves, the friction can result to disposing small metal fragments into the body. This is similar with the issue faced by the metal ball-and-socket design. Metallosis can develop if a metal ion is deposited into the body’s soft tissues, veins, or bones of the patient who went through the implant. A study have shown that the chromium and cobalt ions found in the metal debris can injure various internal organs like the kidney, lymph nodes, spleen, and liver. Different research indicated the relation of metallosis with neurologicall and cardiac failures.

In other words, metallosis can  lead to the necrosis of the soft tissues around the hip implant. When metal fragments are deposited over a long period of time into the soft body tissue, the larger the damage could get.

Some patient can suffer from several lump growths beneath the skin. These lumps are sacs filled with fluid made by the immune system to prevent the metal ion from poisoning the body.

In the previous years, a stryker hip replacement lawsuit has grown in numbers. Many patients have filed their hip implant product liability complaints in the hopes of financial compensation. It is greatly advised for injured patients to seek immediate legal counsel as soon as the first symptoms of hip implant failure is observed.