Man Claims Manufacturer Failed to Recall Implant in Zimmer Hip Litigation

In January of 2007, Thompson underwent full hip replacement surgery. Four years later, he started experiencing pain and other complications relating to the loosening of his Durom Cup hip implant, which compelled him to seek the counsel of Zimmer hip attorneys. He filed his lawsuit in the California Superior Court in the County of Los Angeles, claiming that the manufacturer failed to issue an appropriate recall of a device the company knew was defective.

Complaint Joins Many Other Zimmer Hip Lawsuits

Many other victims of complications from hip implants are filing Zimmer Hip lawsuits alleging an array of side effects, including painful hip implant loosening and metal poisoning resulting from components in the implant improperly rubbing up against one another. Some of these complications from hip implant have forced patients to undergo revision surgery, which is both costly and painful.

FDA Responds to Complications from Zimmer Hips

The FDA issued a statement in March 2012 that it would evaluate the safety of a class including various metal-on-metal hip replacement implements, of which the Zimmer implants are a member. The Agency will solicit opinions of medical professionals, review adverse side effect reports and analyze medical research regarding the safety and efficacy of these implants. This information will be used to assess the safety, reliability and continued monitoring of this class of hip replacement implants.

Zimmer hip recall not initiated

A number of plaintiffs are claiming that their hip replacement system failed much earlier than it would be expected to; Zimmer hip attorneys are helping many of them deal with the legal aspect of their case. They are trying to claim damages as a result of complications from hip implant, and more and more cases are coming up as time goes on. Dislocation, pain, and metal poisoning are all side effects that have been linked to hip replacement systems, and lawsuits are claiming that Zimmer did not do enough to warn patients about the risk of side effects.

Neither Zimmer itself nor the Food and Drug Administration have initiated a hip implant recall, even though many patients and their physicians have urged them to. Zimmer did suspend sales of the Durom Cup hip replacement system for three months in 2008 in order to examine claims of problems with the device, but came back only with reports of surgical error as opposed to design defect.

Zimmer hip lawsuits claim number of symptoms

Hip complications can manifest with symptoms including pain,  dislocation of the joint, reduced mobility, and a need for Zimmer hip surgery associated with hip implant failure. Despite these concerns, Zimmer Holdings profits continue to grow.

Zimmer hip replacement problems noted in patients

Many patients are pursuing Zimmer Hip litigation after experiencing hip complications including early loosening, metallosis, hip implant failure, and the premature need for revision surgery. The FDA panel is set to meet on the 27th and 28th of June, 2012, and will hear the testimony of researchers, scientists, patients, and medical professionals. They will review device failure rates, patient risk factors, implant complications, the occurrence of metallosis, and other important factors involved in the evaluation of hip replacement systems.

A number of lawsuits have been filed by plaintiffs who have contacted an  attorney in order to file suit against the orthopedics manufacturing giant, hoping to win damages and other costs associated with the hip complications they have undergone. Complaints include hip replacement problems, including metallosis, which is a metal poisoning that takes place when shards of metal flake off into the patient’s bloodstream, which can damage tissues. Premature loosening of the implant is another serious concern in hip lawsuits. These conditions can be a catalyst for the need for painful and dangerous hip revision surgery, which can be extremely costly for a patient.

No recall despite reports

Despite the growing reports of hip replacement problems, there has not been a Zimmer hip replacement recall yet. The FDA ordered 21 metal on metal hip implant manufacturers, including Zimmer, to conduct safety studies on their devices in May of 2011, which could eventually lead to a recall, but has not yet.

Zimmer hip settlement attorneys provides completed task summary

A motion was submitted by co-liaison counsel for the plaintiffs in the Durom Cup hip implant MDL on the 2nd of March 2011. This motion detailed the time and expenses accrued to the Zimmer hip lawyer in the Durom cup lawsuit. The appointment, according to the motion, was made on the 23rd of September, 2010. A case management order was issued on the 1st of January, 2011, that stated that each plaintiff procuring a hip settlement would use 4 percent of their settlement to help pay for time and expenses associated with the use of the liaison counsel.

The counsel performed a number of tasks, according to the motion, that provided a common benefit to all hip replacement lawsuit plaintiffs, which included “setting up and coordination the mediation protocol, negotiating discovery requests, addressing scheduling issues, [and] attending court conferences.” The total time was calculated at 956.1 hours in total, which resulted in a total cost of $538,410 which figures in at $563.13 per hour.

Plaintiffs continue to file Zimmer hip replacement lawsuits

Plaintiffs across the country are continuing to file Durom Cup hip replacement lawsuits after experiencing Zimmer hip failure from what they consider faulty hip replacement systems. Those involved in the multidistrict litigation case taking place are plaintiffs who are asking for more than $75,000 in hip settlements.

The plaintiff, Alice L. Hoag, underwent a total hip arthroplasty in December 2006 during which she was implanted with the Metasul Durom Acetabular Component. The lawsuit states that the surgeons implanted the device correctly, and that initially the surgery was successful. However, Hoag subsequently began to experience severe pain and weakness in her hip area, which has limited her mobility and had a detrimental effect on her quality of life. She filed her lawsuit, with the assistance of lawyers, on March 27, 2012 in the Superior Court for the State of California, County of Los Angeles.

Zimmer failed to warn doctors or patients of design’s defects, lawsuit charges

Hoag’s lawsuit claims that the her injuries were caused by the allegedly defective design of the Cup, stating that the metal component may fail to fully attach to the pelvis. When the component becomes loose or separates from the pelvis, it can move freely around the hip socket, rubbing against the bone and causing friction and crippling pain to the patient.

The five-count lawsuit charges Zimmer with failure to warn patients or the medical community about the alleged defect and risk of the potential failure of the device to fully attach to the pelvis, causing subsequent complications. By not warning patients and doctors of this risk, Zimmer misled patients and doctors into believing the Cup was safe, the lawsuit claims. Hoag is seeking compensation for pain and suffering, disability, disfigurement, loss of income, medical and hospital expenses, and rehabilitative and pharmaceutical costs.

More than 1,600 patients have reported Zimmer hip problems

Hoag is just one of many hip patients who have experienced implant failure. The New York Times reports that from 2007 to June 2011, more than 1,600 complaints were filed with the FDA over alleged Zimmer hip complications. Many of these patients were forced to undergo a revision surgery in order to correct the problems. In July 2008, the company issued a recall of the Zimmer hip implant, temporarily suspending sales of the device because of the unusually high incidence of reported hip problems.

Premature loosening leads to lawsuit

Gonzales’ lawsuit is based on the claim that her hip replacement system loosened prematurely, after she was implanted with two Durom Cup systems–her right hip was replaced in October of 2006, and her left hip was replaced in February of 2007. Both surgeries were performed at the Tri-City Medical Center in San Diego, California. She says that shortly after she was implanted with the devices she began experiencing pain and other symptoms consistent with the loosening of the acetabular  cups used in her hip replacement systems.

Gonzales and her Zimmer hip attorneys claim that the design of the Durom cup prevents the device from seating properly in the socket portion of the hip. This could prevent bone from growing in, which is necessary to fix the device permanently to the patient’s hip. If this doesn’t happen, loosening of the implant may occur. Gonzales has had to undergo revision surgery as a result of the hip implant failure she has experienced.

Zimmer hip recall hasn’t happened

Although Zimmer halted sales of the Durom Cup device on the 22nd of July, 2008, the device was quickly reinstated to the orthopedics market, claiming that any complications from hip implant experienced were the result of surgical error and not any design defects. However, a number of plaintiffs have chosen to take action against the device manufacturer and, like Gonzales, are asking for compensation for the injuries they suffered that have been linked to hip replacement devices.

Hip lawsuits have grown significantly in number over the last year, with a number of plaintiffs seeking compensation for Zimmer hip injuries, claiming that they suffered from hip failure and other side effects associated with hip replacement devices, most commonly the Durom Cup hip replacement device.

Zimmer recall not in the cards

Because of the growing concern about complications from Zimmer hip such as implant loosening, a form of metal poisoning known as metallosis, and the need for revision surgery much earlier than expected, a number of patients and medical experts have been wondering whether Zimmer or the Food and Drug Administration will initiate a hip recall, but neither party seems to be prepared to make that decision.

Zimmer did temporarily pull the Durom Cup device from the market for three months in 2008 to examine reports of  hip replacement problems, but the product was returned to the market. Zimmer claims that any problems associated with their hip replacement devices should be blamed on surgical practice and not any problems associated with the devices themselves.

The Food and Drug Administration, who also has the power to initiate a device recall of the product, has not done so but did in May of 2011 require all metal-on-metal hip implant manufacturers to study the effects of metallosis on recipients of their implants.

MDL focuses on metallosis

Metallosis is one of the most commonly cited complications associated with Zimmer hip devices, and is one of the major focuses of the ongoing multidistrict litigation case, which is currently taking place in New Jersey. Originally consisting of 45 cases, there are now 75 lawsuits within the Zimmer Hip litigation awaiting trial in this consolidated litigation case.

The only requirement for a device’s approval through the fast track process is that the manufacturers prove that it is “substantially similar” to a device that is already on the market and has been approved by the FDA. The New York Times published a report a little over a year ago that criticized the FDA’s fast track process–although this article focused on the DePuy ASR hip replacement device, similar concerns have been brought up with the Durom Cup hip replacement system as it followed a similar clearance pattern.

Zimmer hip replacement recall: not yet initiated

Despite the growing number of complaints against the device manufacturer, many of which have turned into lawsuits that are trying to gain compensation from the device manufacturer for injuries that patients have experienced. Patients have reported problems including limited mobility and loosening of the implant parts, and although Zimmer did pull the device from the market for three months for evaluation, ultimately it was re-released with the claim that any problems were due to problems with the surgical technique used to implant the device and not the device itself or any design or manufacturing flaws. Neither Zimmer nor the Food and Drug Administration have chosen to initiate a Zimmer hip recall.

Zimmer complaints criticize FDA method

A number of lawsuits are citing the FDA’s fast track approval process as the reason for their complications–they assert that, had the Food and Drug Administration require more stringent testing of the devices, the potential complications may have been noticed and weeded out before it had a chance to put patients at risk. Unfortunately, this was not the case, and lawsuits continue to be filed across the country.

Zimmer Hip Lawsuits Allege Metal Poisoning

Traditional hip implants combine metal and plastic parts, but metal-on-metal hip devices simulate the hip joint with both a metal ball and metal socket. These components can rub together and create friction, causing metallic particles, including cobalt and chromium, to saturate the bloodstream and travel throughout the body. Metallosis is a common  lawsuit allegation, although no definitive link has been established between Zimmer’s implants and metallosis. Likewise, neither the Food and Drug Administration (FDA) nor the manufacturer has issued a recall of the Zimmer hip implant for the company’s metal-on-metal devices.

Metallosis Aspect of Zimmer Hip Implant Failure

Metallosis not only has long-term health ramifications due to increased metal levels in the bloodstream, but can also immediately affect the tissues surrounding the implant. The body’s “scavenger” cells process the metallic fakes, turning them into biologically active metal ions that interact with a patient’s tissue and produce an immune response that can result in serious tissue damage within two years. A recent New York Times article defined this effect as “a biological dead zone.” After examining the tissues of one patient’s Zimmer hip implant,  medical professionals described finding “matted strands of tissue stained gray and black; a large strip of muscle near the hip no longer contracted.”

No Zimmer Hip Replacement Recall – Yet

The New York Times also analyzed FDA adverse event reports regarding metal-on-metal hip implants and revealed that 5,000 complaints had been filed in just the first six months of 2011. This data implies that, though only a small percentage of the United States’ 500,000 all-metal hip implants have resulted in Zimmer hip complications, these statistics may grow in the future. However, the likelihood of a future Zimmer recall is as-yet unknown, since researchers have not uncovered the true risk and consequences of metallosis. For example, even though patient does not experience debilitating pain, he or she may already suffer from serious tissue damage. Nonetheless, the FDA has already ordered metal-on-metal implant manufacturers, including Zimmer, to conduct studies into the causes and repercussions of hip failure.

This is somewhat more of a commitment as, if the device does not fail early as some Zimmer hip replacement systems have been known to do, the lifespan of such as hip replacement system could be 15 to 20 years. “By monitoring patients every year,” Dr. Susanne Ludgate, clinical director of the Medicines and Healthcare Products Regulatory Agency, notes to the New York Times, “any complications will get picked up earlier and more complex surgery of the patient may be avoided.”

Zimmer hip lawsuits mounting

Amidst a number of Zimmer hip lawsuits that have been filed by patients who have enlisted the help of a Zimmer hip lawyer, there is no talk of a Zimmer hip implant recall. ALthough the device was pulled from shelves in 2008 for a closer examination of problems associated with the device, it has since been re-released with minor changes and is still distributed to patients worldwide.

One of the most commonly cited side effects involved in many who file a Zimmer hip lawsuit is metallosis, which takes place when the two parts of the metal on metal hip replacement system rub against one another and small pieces of cobalt and chromium make their way into the surrounding tissue and the bloodstream. This can lead to inflammation of soft tissue and pain around the joint. A number of patients have experienced complications from hip implant replacement have had to undergo a second Zimmer hip surgery as a result.

Brits stop short of Zimmer hip recall

British researchers believe that problems associated with metal on metal hip replacement systems such as the Zimmer Durom Cup are significant. However, they have not recommended a Zimmer hip replacement recall.

About one third of the 250,000 hip replacement surgeries performed in the United States annually involved metal on metal hip replacement devices until recently. Many medical experts think that it is no one brand or device but metal on metal hip replacement systems as a whole that are truly the problem.