The Stryker Hip Master Settlement Agreement: Terminology

Important Terms to Know for Stryker Hip Implant Recipients

Stryker Hip Implants—Stryker Orthopedics is a global leader in the development, manufacture and sale of hip and knee implants. Although the Stryker ABGII and Rejuvenate were recalled, the Accolade is still being marketed.

Stryker Hip Implant—When physical therapy and/or pain medications fail to fix a hip issue, a surgeon may perform total hip replacement, partial hip replacement or hip resurfacing on the patient in order to treat the hip disease or deterioration. If you received a recalled Stryker ABGII or Rejuvenate, you may have suffered metallosis or cobalt and chromium poisoning.

Stryker Hip Implant Failure—Stryker hip implant failure can occur when the femoral or acetabular portions of the implant become loose. This failure may or may not cause pain, but will most always require surgical correction. 

Stryker Hip Recalls—The Stryker Rejuvenate and ABGII were recalled in July, 2012.

Stryker Hip Trunnions—Stryker hip trunnions are small metal pieces—also known as tapers—located on either end of the Stryker ABGII and Rejuvenate hip implants. Trunnions can trap body fluids, leading to corrosion and the release of metal ions. The trunnions on the neck portion snap into the stem on one end and the ball on the other.  

Stryker Hip Fretting—Fretting occurs when there is repeated rubbing between two surfaces; over time material is removed from one or both surfaces which are in contact with one another. In a Stryker hip replacement, fretting occurs when the modular stem and neck components move during periods of activity, resulting in friction which will shear away cobalt and chromium ions.

Stryker Hip Corrosion—Corrosion is the gradual destruction of a metal surface, generally due to a chemical reaction within its environment. The human body, with a pH of around 7.4 and a temperature of 98.6 degrees is not especially a hospitable environment for an implanted metal alloy. There are several types of corrosion which can occur in a Stryker hip implant including stress corrosion, crevice corrosion, galvanic corrosion, pitting and intergranular corrosion. While titanium is the metal least likely to succumb to corrosion, its tendency to suffer oxygen diffusion during fabrication makes it a more brittle metal than cobalt and chromium.

Stryker Hip Cross Ionization

Stryker hip cross ionization occurs when mismatched metals are paired together—in this case, a titanium stem with a cobalt and chromium neck piece. One study showed that only 28% of hip implants using similar alloys exhibited moderate to severe corrosion, while 42% showed moderate to severe levels of corrosion when mismatched metals were used.

Stryker Hip Metallosis—When metal ions shear away from the Stryker hip implant during periods of activity, and burrow into the surrounding hip tissues, metallosis can occur. Metallosis has also been described as the macroscopic staining of soft tissue associated with abnormal wear. The symptoms of metallosis include: pain in the hip, groin, or thigh, severe inflammation in the hip region, deterioration or death of hip bone and tissue, total failure or the Stryker implant and the necessity of Stryker hip revision surgery. 

Stryker Hip Chromium & Cobalt Blood Poisoning—Microscopic metal ions which shear away from the Stryker implant and travel to the bloodstream can result in the buildup of cobalt and chromium ions. The symptoms of Stryker hip chromium & cobalt blood poisoning include:

·         DNA disrupt and the inability of the body to repair DNA

·         Liver necrosis in the case of high levels of chromium

·         Renal impairment or failure

·         Respiratory issues including asthma and shortness of breath

·         Loss or impairment of hearing and vision

·         Decreased numbers of sperm, sperm abnormalities, reproductive disorders

·         The formation of pseudotumors

·         Skin rashes and severe dermatitis

·         An increase in the development of certain types of cancers.

·         Hypothyroidism

·         Cardiovascular issues including fatal cardiomyopathy

·         Neurological issues including tinnitus, vertigo, chronic headaches, loss of memory, decline of cognitive function, depression, anxiety, irritability

·         Fatigue, poor concentration

·         Atrophy of the muscles

·         Seizures, tremors, convulsions

Stryker Hip Blood Toxicity—Stryker hip blood toxicity is much the same as cobalt and chromium poisoning, with the same symptoms. Some people appear to be more sensitive to heavy metals and will experience Stryker hip blood toxicity symptoms at relatively low levels of cobalt and chromium while others can have much higher levels but have not experienced adverse healthy symptoms yet.

Stryker Hip ALVAL—ALVAL (aseptic lymphocyte dominated vasculitis associated lesion) is another type of soft-tissue mass, much like a pseudotumor. It is believed ALVAL results when bone dissolution occurs, and most ALVAL patients will experience pain in the groin area. When fluid is aspirated from the hip area, it will be thick and grey-green in color when ALVAL is present. Some research suggests that ALVAL may be due to misalignment of the Stryker hip implant.

Stryker Hip Pseudotumors—Pseudotumors are generally non-infectious, non-cancerous, space-occupying tumors in the hip region. Netherlands research concluded that recipients of metal hip implants had four times the risk of developing a pseudotumor when they presented with elevated cobalt and chromium ion levels. The patient may be unaware of the tumor until it has grown quite large, causing hip or groin pain, swelling in the upper leg, foot or ankle region, a clicking or popping noise in the hip area, a nerve disorder leading to weakness or immobility, or a discernible lump in the hip. Pseudotumors can place pressure on surrounding body parts, leading to other serious health issues.

Stryker Hip Necrosis—Stryker hip necrosis is the death of tissue or bone, resulting from cobalt and chromium ions shearing away from the implant, lodging in the surrounding hip tissues.

Stryker Hip Revision Surgery—When a patient develops symptoms of serious metal toxicity, hip failure or metallosis, he or she may be forced to undergo Stryker hip revision surgery in which the Stryker implant is removed and replaced with a non-metal device. Stryker revision surgery is considered especially risky as the operation can take as long as three hours, and the recovery time can be as long as six weeks.

Stryker Hip Broadspire Letter—In November, 2012, Stryker brought in former DePuy CEO, David Floyd, as the new president. Floyd brought in Broadspire—one of the largest insurance and claims adjusters in the world—in an effort to minimize the damage to Stryker, just as he had with DePuy and Johnson & Johnson. A Broadspire letter was sent to recipients of the recalled Rejuvenate and ABGII, offering to pay for the costs of revision surgery—in return for access to the patient’s medical records. It is important that consumers speak to a knowledgeable Stryker hip attorney prior to signing a Broadspire letter.

Stryker Hip Lawyer—A knowledgeable Stryker hip lawyer will ensure your rights are protected and that you receive the best settlement available to cover your medical expenses, lost wages, loss of future earnings and pain and suffering.

Stryker Hip Lawsuit—Currently over 2,300 Stryker lawsuits have been filed against the company, alleging the company was aware the Rejuvenate and ABGII were dangerous long before the recall, and that the design of the implants was defective.

Stryker Hip Multidistrict Litigation—The majority of the Stryker hip lawsuits are filed as Stryker hip multidistrict litigation, primarily in the states of Minnesota and New Jersey. Multidistrict litigation is a special civil procedure, used to handle pre-trial steps for similar cases which have at least one common issue.

Stryker Hip MDL Consolidation—Stryker hip MDL consolidation is a special procedure in which federal civil cases from around the country are transferred to one court. One judge manages the litigation during the pretrial and discovery process. If a case does not settle during MDL, it is sent back to the original court for trial. Congress created the MDL system to coordinate federal complex litigation filed in multiple districts as a way of saving time, money and resources.

Stryker Hip New Jersey Consolidation—New Jersey Superior Court Judge Brian Martinotti is presiding over the Stryker hip New Jersey MDL consolidation which currently includes over 1,140 cases. The first Stryker New Jersey consolidation suit was filed by Weitz & Luxenberg shortly after the 2012 recall.

Stryker Hip Statute of Limitations—The statute of limitations varies from state to state, from one year to ten years, with most states operating under a two-year statute. In many states, the statute begins from the time of the injury, although this can be a complex issue, as the patient may not have tied their injury to the Stryker hip implant until after the recall was issued.

Stryker Rejuvenate Hip Implants—On April 14, 2008, Stryker submitted the Stryker Rejuvenate Modular Hip System to the FDA for approval, which was granted on June 3, 2008 under the 510(k) process which requires only that the implant be substantially similar to an existing product. The Stryker Rejuvenate hip implants were not widely marketed until early 2010.

Stryker Rejuvenate Hip Implant—Unlike traditional hip implant designs which include a one-piece neck and stem and are known as a monoblock design, the Stryker Rejuvenate hip implant includes six stems and sixteen necks, allowing the surgeon to custom-fit the device to the patient in a more anatomically correct implantation. The stem of the Rejuvenate is titanium, while the neck is constructed of cobalt and chromium and the stem of the Rejuvenate is longer than that of the ABGII.

Stryker Rejuvenate Hip Implant Failure—Stryker Rejuvenate hip implant failure can occur when the components loosen, generally causing pain and popping or clicking noises. Stryker hip implant failure may be more likely in the Rejuvenate than in the ABGII as the longer Rejuvenate stem is implanted more deeply into the femur and the hydroxyapatite porous coating of the Rejuvenate is rougher and deeper which allows the bone to grow more solidly into the device—and makes it much more difficult to remove.

Stryker Rejuvenate Hip Recall—The Stryker Rejuvenate was recalled at the same time as the Stryker ABGII, in July, 2012, due to concerns regarding a higher-than normal failure rate as well as the implant’s propensity to suffer fretting and corrosion, leading to the excess release of cobalt and chromium ions.

Stryker Rejuvenate Hip Trunnions—Stryker Rejuvenate hip trunnions are also known as tapers, and connect the neck portion at either end to the stem and the acetabular cup. These metal trunnions can trap body fluids, leading to greater levels of corrosion, and a greater likelihood of metallosis and metal toxicity.

Stryker Rejuvenate Hip Fretting—When two surfaces—such as the titanium stem of the Stryker Rejuvenate and the cobalt and chromium taper surface—rub against one another during periods of patient activity, Stryker Rejuvenate hip fretting can result.

Stryker Rejuvenate Hip Corrosion—Stryker Rejuvenate hip corrosion occurs when the metal parts rub against one another and body fluids are trapped under metal surfaces. Metal ions shear away following corrosion, causing metallosis or metal poisoning. When surgeons remove a Stryker Rejuvenate, in some cases they note the presence of what appears to be “black rust” covering the removed Stryker Rejuvenate implant. 

Stryker Rejuvenate Hip Cross Ionization—Stryker Rejuvenate hip cross ionization occurs when two metals are paired with one another. Despite research spanning decades which details the adverse effects of cross ionization, Stryker chose to pair a titanium stem with a cobalt and chromium neck in the Stryker Rejuvenate, resulting in cross ionization.

Stryker Rejuvenate Hip Metallosis—Stryker Rejuvenate hip metallosis can occur when the metal device releases excess amounts of cobalt and chromium ion debris. When unintended contact between the metal parts of the Rejuvenate come in contact with one another during periods of activity, microscopic metal ions shear away and can lodge in the surrounding hip tissues. The human body perceives these tiny metal ions as foreign bodies, and attempts to expel them from the body by sending white blood cells (macrophages) to attack the metal shards, however the result in inflammation, pain, loss of bone and tissue, total hip failure and the necessity of hip revision surgery. It appears that women, all of those small in stature and those who are obese have a higher risk of metallosis. 

Stryker Rejuvenate Hip Chromium & Cobalt Blood Poisoning—When the cobalt and chromium ions make their way to the bloodstream, levels of the heavy metals can build up, causing serious, adverse health effects such as:

·         DNA disrupt and the inability of the body to repair DNA

·         Liver necrosis in the case of high levels of chromium

·         Renal impairment or failure

·         Respiratory issues including asthma and shortness of breath

·         Loss or impairment of hearing and vision

·         Decreased numbers of sperm, sperm abnormalities, reproductive disorders

·         The formation of pseudotumors

·         Skin rashes and severe dermatitis

·         An increase in the development of certain types of cancers.

·         Hypothyroidism

·         Cardiovascular issues including fatal cardiomyopathy

·         Neurological issues including tinnitus, vertigo, chronic headaches, loss of memory, decline of cognitive function, depression, anxiety, irritability

·         Fatigue, poor concentration

·         Atrophy of the muscles

·         Seizures, tremors, convulsions

Stryker Rejuvenate Hip Blood Toxicity—Stryker Rejuvenate hip blood toxicity occurs when there is a buildup of cobalt and chromium ions in the body. Some people are much more sensitive to heavy metals in their body than others, and will experience adverse symptoms as lower levels.

Stryker Rejuvenate Hip ALVAL—ALVAL (aseptic lymphocyte dominated vasculitis associated lesion) is a soft, non-cancerous mass, believed to result from the dissolution of bone. Stryker Rejuvenate ALVAL can cause tissue necrosis, with varying symptoms from patient to patient. Most patients with ALVAL will have pain when asked by their physician to perform a straight-leg raise. When fluid in the hip is aspirated, it may be thick and grey-green in color when ALVAL is present. Depending on how severe the Stryker Rejuvenate hip ALVAL is, revision surgery may be warranted.

Stryker Rejuvenate Hip Pseudotumors—Stryker Rejuvenate hip pseudotumors are space-occupying tumors in the hip regions which are usually non-infectious and non-cancerous, however can cause hip or groin pain, nerve damage leading to weakness or the inability to walk, swelling in the thigh or foot and ankle region and a clicking or popping sound in the hip region. An improperly positioned hip implant is more likely to result in pseudotumors.

Stryker Rejuvenate Hip Necrosis—When cobalt and chromium ions shear away from the Stryker Rejuvenate hip implant and lodge in nearby hip tissues, those tissues—as well as the hip bone—can deteriorate and die, leading to Stryker Rejuvenate hip necrosis.

Stryker Rejuvenate Hip Revision Surgery—Stryker Rejuvenate hip revision surgery is considered even riskier than ABGII surgery as the stem of the Rejuvenate is particularly long and is implanted so deeply into the femur that when the surgeon attempts to remove the stem, the femur can shatter, leaving the patient in a wheelchair until a new femur can be built.

Stryker Rejuvenate Hip Broadspire Letter—Just like the DePuy ASR Broadspire letter sent out after the ASR recall, the Stryker Rejuvenate hip Broadspire letter was sent out to recipients of the recalled Rejuvenate. The letter offered to pay for revision surgery costs in return for unfettered access to the patient’s medical records. If you received a Stryker Rejuvenate hip Broadspire letter, it is important that you not sign anything before speaking to a knowledgeable Stryker hip attorney. If you have already signed a Stryker Rejuvenate hip Broadspire letter, you should still speak to an attorney who will work hard to protect your rights.

Stryker Rejuvenate Hip Lawyer—A Stryker Rejuvenate hip lawyer is extremely knowledgeable regarding all aspects of the Rejuvenate implant itself, as well as the recall and the current litigation against Stryker regarding the Rejuvenate. A Stryker Rejuvenate hip lawyer will always have his or her client’s best interests at heart and will protect the rights of those injured by a Stryker Rejuvenate hip implant.

Stryker Rejuvenate Hip Lawsuit—Soon after the Stryker Rejuvenate hip recall, lawsuits began to be filed against the company. Many believe Stryker was well-aware of at least some of the dangers associated with the Rejuvenate long before the recall was issues. Over 2,300 lawsuits have been filed against Stryker for harm suffered from a Rejuvenate or ABGII.

Stryker Rejuvenate Hip Multidistrict Litigation—Multidistrict litigation is implemented when there are a large number of lawsuits filed against one defendant, with much of the same information and evidence in common. Stryker Rejuvenate hip multidistrict litigation has currently consolidated the majority of the cases in New Jersey and Minnesota.

Stryker Rejuvenate Hip MDL Consolidation—When there are a number of federal civil cases against one defendant, these cases may be transferred to one court. One judge will manage the litigation during the pretrial and discovery process. Stryker Rejuvenate hip MDL consolidation also has a number of cases in Florida and a handful in other states.

Stryker Rejuvenate Hip New Jersey Consolidation—Judge Brian Martinotti is presiding over the Stryker Rejuvenate hip New Jersey Consolidation which currently includes over 1,100 cases.

New Jersey Superior Court Judge Brian Martinotti is presiding over the Stryker hip New Jersey. On April 1, 2014, Judge Martinotti entered a case management order aiming to resolve the Stryker Rejuvenate cases in a timely manner. Judge Martinotti ordered all parties involved in Stryker Rejuvenate hip New Jersey consolidation to “confer in an attempt to resolve the remaining issues.”

Stryker Rejuvenate Hip Statute of Limitations—The statutes of limitations governs the amount of time consumers have to file a product liability case against the manufacturer of a defective or dangerous device. Most states have a two-year statute, although some states have statutes as short as one year while others have statutes as long as ten years. The statute may begin to run when the injury occurs, or when it was discovered—or should have been discovered.

Stryker ABGII Hip Implants—The Stryker ABGII hip implants gained FDA approval in 2009, although they were not widely released until early 2010. The implants were considered to have an extremely innovative design, using a ceramic ball rather than a metal ball, which was believed to lessen the chance of corrosion and fretting.

Stryker ABGII Hip Implant—Like the Rejuvenate, the Stryker ABGII hip implant offers a variety of neck and stem components which allows surgeons to custom-fit the device to the individual patient, according to size, body type and level of activity. The Stryker ABGII hip implant design was also believed to add anatomical stability, due in part to the titanium stem which was designed to follow the natural contours of the femur. The Stryker ABGII hip implant offers eight left and right stems and ten modular necks in varying lengths and angles.

Stryker ABGII Hip Implant Failure—When the modular components of the Stryker ABGII loosen, Stryker ABGII hip implant failure can result. When implant failure occurs, the patient may be forced to under Stryker ABGII hip revision surgery. The failure rate of the Stryker ABGII has been placed anywhere from 12% to as high as 65%.

Stryker ABGII Hip Recall—The Stryker ABGII was recalled in July, 2012, at the same time as the Stryker Rejuvenate. At the time of the recall, Stryker noted a higher-than-normal failure rate, as well as a higher likelihood of the implant undergoing corrosion and fretting, leading to the excess release of metal ions.

Stryker ABGII Hip Trunnions—Trunnions are the tapered metal portion on either end of the Stryker ABGII, which can rub against other metal parts, leading to fretting and corrosion. Instead of providing the extra “give” and adapting to the patients’ size and activity level, the trunnions have apparently created additional stress, leading to micro-motion and fraying.

Stryker ABGII Hip Fretting—When two metal surfaces repeatedly rub against one another, over time microscopic metal ions will shear away from the device. Stryker ABGII hip fretting occurs when the stem and neck components—including the tapered trunnions—move during periods of activity.

Stryker ABGII Hip Corrosion—The environment in the human body makes it extremely likely that metal corrosion will occur when a metal device is implanted. The metal device in the body is constantly exposed to extracellular tissue fluid, and the exposed metal surface of the implant undergoes an electrochemical dissolution of material.

Stryker ABGII Hip Cross Ionization—Many believe that where the neck taper attaches to the stem, cobalt and chromium ions are released, causing cross-ionization between the titanium stem and the cobalt and chromium neck. Despite much research which concluded there could be serious problems with pairing mismatched metals, Stryker ignored the research and paired mismatched metals, leading to Stryker ABGII hip cross ionization.

Stryker ABGII Hip Metallosis—Metallosis in medical terms is defined as aseptic fibrosis or local tissue death caused by the corrosion of a metal device implanted in the body—and the subsequent release of metal ion debris. When metal shards lodge in the surrounding hip tissues, metallosis can occur with the following symptoms: chronic pain in the hip, groin or thigh, inflammation of the hip tissues, loss of bone and tissue, loosening of the implant, total implant failure and the necessity of hip revision surgery.

Stryker ABGII Hip Chromium & Cobalt Blood Poisoning—When the cobalt and chromium ions reach the bloodstream and begin to build up, Stryker ABGII hip chromium & cobalt blood poisoning can occur. The symptoms of Stryker ABGII hip chromium & cobalt blood poisoning include the following:

·         DNA disrupt and the inability of the body to repair DNA

·         Liver necrosis in the case of high levels of chromium

·         Renal impairment or failure

·         Respiratory issues including asthma and shortness of breath

·         Loss or impairment of hearing and vision

·         Decreased numbers of sperm, sperm abnormalities, reproductive disorders

·         The formation of pseudotumors

·         Skin rashes and severe dermatitis

·         An increase in the development of certain types of cancers.

·         Hypothyroidism

·         Cardiovascular issues including fatal cardiomyopathy

·         Neurological issues including tinnitus, vertigo, chronic headaches, loss of memory, decline of cognitive function, depression, anxiety, irritability

·         Fatigue, poor concentration

·         Atrophy of the muscles

·         Seizures, tremors, convulsions

Stryker ABGII Hip Blood Toxicity—Stryker ABGII hip blood toxicity is much the same as cobalt and chromium poisoning.  “Normal” levels of cobalt in the human body are below 1.0, and anything above 5.0 is generally considered toxic.

Stryker ABGII Hip ALVAL—Patients who suffer pain in the groin area and are unable to perform a straight-leg raise without significant levels of pain may be suffering from Stryker ABGII hip ALVAL. The death of hip tissue is a key feature of ALVAL, and when a physician suspects ALVAL, he or she may perform hip aspiration. If the aspirated liquid is gray-green in color and very thick, ALVAL may be present. Many physicians believe ALVAL is under-diagnoses because of the somewhat non-specific symptoms.

Stryker ABGII Hip Pseudotumors—Pseudotumors are very common in metal hip implants—about four times as common as for those with implants made from ceramic or polyethylene. Those who are particularly sensitive to heavy metals, may have a higher-than-normal risk of developing pseudotumors. Pseudotumors may also be related to an implant which is less-than-perfectly positioned.

Stryker ABGII Hip Necrosis—When metallosis has reached a certain level, the hip tissue and bone may be affected, in that it will deteriorate or suffer death. This is known as Stryker ABGII hip necrosis.

Stryker ABGII Hip Revision Surgery—While not as risky as Stryker Rejuvenate hip revision surgery, Stryker ABGII hip revision surgery nonetheless is riskier than the initial hip implantation surgery. The surgery can take as long as three hours, leaving the patient open to infection and excessive blood loss. Recovery time for Stryker ABGII hip revision surgery can take as long as six weeks, requiring the patient to be off work for an extended period of time.

Stryker ABGII Hip Broadspire Letter—Stryker hired DePuy CEO David Floyd as their new president after the Stryker recall was issued. Just as he had with DePuy, Floyd brought in Broadspire—one of the world’s largest insurance and claims adjusters. The goal was to minimize the damage to Stryker by sending a “Broadspire Letter” to all those who had undergone Stryker revision surgery, offering to pay the costs of that surgery in return for access to the patient’s medical records. Most attorneys believe the Stryker ABGII hip Broadspire letter was a blatant attempt to gain unrestricted access to patient medical records, then use those records against the patient at trial by saying the medical problems experienced were related to another health issue rather than the Stryker implant.

Stryker ABGII Hip Lawyer—Any person who received a recalled Stryker ABGII hip implant should definitely speak to a knowledgeable, experienced Stryker ABGII hip lawyer to ensure their rights are fully protected and they receive the best settlement possible.

Stryker ABGII Hip Lawsuit—Those injured by a Stryker ABGII hip implant may want to consider joining others in the Stryker ABGII hip lawsuits. Currently there are more than 2,300 lawsuits filed against Stryker. Considering there were over 20,000 ABGII and Rejuvenate implants sold, that number is expected to rise.

Stryker ABGII Hip Multidistrict Litigation—Most Stryker ABGII cases are filed under Stryker ABGII hip multidistrict litigation which allows better use of resources, time and money, benefitting all those involved.

Stryker ABGII Hip MDL Consolidation—When the number of cases against the manufacturer of a dangerous or defective device grow to a certain level, all those federal cases from around the country may be transferred to a single court where one judge will manage the litigation during the discovery and pretrial process.

Stryker ABGII Hip New Jersey Consolidation—Judge Brian Martinotti is currently presiding over the Stryker ABGII hip New Jersey consolidation which contains over 1,140 cases (ABGII and Rejuvenate combined). Judge Martinotti has entered a case management order which aims to resolve all the Stryker ABGII and Rejuvenate cases in a timely manner.

Stryker ABGII Hip Statute of Limitations—Those who have been injured from a dangerous or defective device have a specific length of time in which to file a lawsuit against the manufacturer of the device. The statutes vary from state to state—from one to ten years—with the average being two years from the time the injury occurred.

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