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Biomet Hip Replacement

Contact the Biomet hip replacement injury attorneys at the Drug Law Center to discuss your rights to financial compensation if you have suffered serious injury by a defective medical device.

What is a Biomet Hip Replacement?

Biomet Hip Replacement RecallsZimmer-Biomet manufactures a variety of hip replacement devices to restore or replace a portion or all of a hip that is damaged by injury or in individual suffering from some condition like arthritis. Some of the products produced by the medical device manufacturer are used in hip resurfacing procedures or hip replacements surgeries that involve the acetabular liners and shells, and femoral heads and stems. Biomet first developed their M2a Magnum hip implant arthroplasty system in 2000.

Who Needs Hip Replacement Surgery?

Many individuals suffer from osteoarthritis in their hip joint where problems caused by wear and tear become significantly worse over time. At some point, arthritis causes a significant pain and discomfort in the groin area, buttocks, and lower back. Pain in the joint area is usually the result of the damaging effects of osteoarthritis where smooth cartilage lining the end of the bones are worn away, limiting comfortable joint movement.

Other individuals suffer from a congenital predisposition to where their hip bones wear out early in life. Some suffer from hip dysplasia were stress on cartilage is caused by a shallow socket. Other patients begin losing cartilage caused by if impingement where the socket in the ball of the joint bump into one another. Finally, very few patients develop arthritis in their joint after a hip injury. For each of these patients, replacing the existing joint with the synthetic one built out of ceramic, plastic or metal can be life-changing.

However, doctors recommend postponing surgery until there is no other option available like joint injections, physical therapy, and anti-inflammatory drugs. At some point, the patient has no alternative treatment to alleviate pain and improve mobility to sustain their return to a more active lifestyle. However, waiting too long until intense pain can diminish the quality of life can cause significant emotional problems.

Less than two decades ago, doctors were telling their patients that their new hip replacement joint would last approximately a decade or more. However, the improvement in technology, and the advancements of synthetic materials, medical device manufacturers have made significant improvements in patient surgery outcomes. Some devices are expected to last decades.

Biomet Hip Replacement Complications

The U.S. Food and Drug Administration (FDA) has reviewed hundreds of reports outlining adverse events and serious side effects after patients have undergone a Biomet M2a hip replacement procedure. In recent years, the number of injuries has prompted hundreds of hip joint replacement injury lawsuits across the United States. This is because the metal on metal device is known to have serious defects in its design. This includes joint friction that produces small metal shards that find their way into the patient’s bloodstream causing metallosis (metal toxicity/poisoning). Common complications associated with the Biomet hip replacement device include:

  • Joint slippage
  • Joint ball dislocation
  • Organ damage
  • Tissue damage
  • Bone fracture
  • Crippling pain
  • Pseudo tumors
  • Metallosis

Biomet Hip Replacement Recall History

  • 2001 – Many patients who underwent Biomet M2a Magnum Hip Replacement surgery suffered serious complications including hip pain, premature loosing of the device, challenges in walking, metallosis, and organ damage. Because of that, the Food and Drug Administration announced a Biomet hip replacement recall stating there was an issue with the ceramic femoral head that fits into the hip socket. The FDA stated there was an unexpected higher than normal fracture rate in patients who experienced broken bones 13 to 27 months after the surgical procedure had been performed. Many of these fractures require revision surgery.
  • June 2012 – The FDA Orthopedic and Rehabilitation Devices Advisory Panel Meeting “reviewed available data and discuss the safety risks and effectiveness of metal on metal hip implants with patients, physicians, researchers, international regulatory agencies, professional societies, and manufacturers. The federal agency discussed a variety of issues associated with implant devices including their failure rates, metal ion testing, patient risk factors, imaging methods, and follow-up post-surgeries considerations.
  • New Jersey 2012 – A federal court in New Jersey has decided to consolidate all federal cases involving Biomet lawsuits into multidistrict litigation court in the Northern District of Indiana. In an effort to streamline the cases during litigation, the judge decided consolidation could make the judicial process more efficient, provide resources to defendants and plaintiffs, and prevent inconsistent rulings during the pretrial phase.
  • October 2016 – The FDA issued a safety communication for public release over concerns on metal on metal hip implants including their benefits and risks. Physicians were warned to “pay close attention to patient populations for which metal on metal hip systems are Be aware of the risk factors that may predispose a device to access where an early failure.” The FDA also warned doctors to “discuss the patient’s expectations and review the potential complications of surgery with a metal on metal hip implant.”

Additional warnings on patient follow-up were discussed alerting doctors to “be aware that there are certain patients who are at risk for increased device wear and/or adverse local tissue reactions (ALTR) and should be followed more closely.” The patients most at risk were:

  • Individuals with bilateral implants
  • Females
  • Those with resurfacing systems with four millimeter or smaller femoral heads
  • Severely overweight individuals
  • Those with suspected chromium, cobalt, nickel or other metal sensitivity
  • Highly physically active individuals
  • Those with suppressed immune systems
  • Individuals diagnosed with renal insufficiency
  • Those taking corticosteroids at high doses

The FDA directed doctors to “follow symptomatic patients with metal on metal hip implants at least every six months.”

$56 Million Biomet Hip Replacement Settlement

In 2014, Zimmer-Biomet reached an agreement to deposit $50 million into an escrow account and pay attorneys working on behalf of injured clients $6 million in legal fees. The settlement involved:

  • February 2014 – The multidistrict lawsuit involving Biomet M2a Magnum metal on metal hip replacement devices will be settled with $56 million from the medical device manufacturer. This settlement involves hundreds of plaintiffs would file lawsuits and courts all across the United States alleging serious injuries developed after their Biomet hip device replacement surgical procedure was performed. The multidistrict litigation case started in 2012 in a federal courtroom in Indiana (Biomet headquarters are located in the state).Biomet agreed to the settlement that requires a $50 million escrow account deposit and an additional $6 million in attorney fees. All existing lawsuits in future cases involved in this settlement are required to be filed prior to April 16, 2014. Plaintiffs involved in the case were expected to receive $200,000 as a base award to settle their lawsuit. Even though Biomet is agreed to the settlement they stringently deny that the hip implant caused damages, losses, or injuries.

    However, the judge stated that “plaintiffs in Biomet are mindful of the uncertainties engendered by litigation and are desirous of settling and compromising their differences by entering into the settlement agreement.” The case was filed in the U.S. District Court, Northern District of Indiana (multidistrict litigation case number 12-02391).

Biomet Hip Replacement Lawsuits

Many individuals who suffered injury after undergoing a Biomet M2a Magnum hip replacement procedure will file a lawsuit against the medical device manufacturer to recover their financial damages. Some of these cases involve:

  • Medical Device Manufacturer Biomet Facing M2a Magnum Hip Replacement Injury LawsuitJanuary 2016 – Once again, Zimmer-Biomet is facing one more M2a Magnum metal on metal hip replacement injury lawsuit, this time filed by California man then alleges the company failed to warn him of the potential severity and risks associated with known side effects of their device. Attorneys working on the plaintiff’s behalf built the case alleging his severe hip replacement injuries were the result of undergoing the surgical procedure. These include metallosis (hip implant metal poisoning) and obstruction of bone and tissue caused by the device.

    The plaintiff received the hip implant in July 2009 and claims he required painful and risky hip revision surgery six years later due to severe pain and other complications. The lawsuit alleges that Biomet failed to perform adequate tests to determine the amount of metal poisoning the device could produce or its failure to ensure the device remain stable and secure years after surgery. The plaintiff is seeking compensatory damages to cover medical expenses, loss of earnings, attorney fees, pain and suffering, and the cost of the lawsuit. This case was filed in the U.S. District Court for the Central District of California.

  • Rhode Island Woman Files Biomet Hip Replacement Injury Lawsuit against Device MakerMarch 2016 – Biomet is returning to court to face a hip replacement injury lawsuit, this time filed by a Rhode Island plaintiff claiming that her serious side effects are the result of defects in the replacement device. Surgeons implanted a Biomet hip replacement device in May 2004. However, by 2013, she required hip revision surgery prematurely.

    Attorneys working on behalf have built the case on the company’s failure to adequately test the product and warned consumers that the implant could fail or loosen within years after the completion of surgery. This case was filed in the U.S. District Court for the Northern District of Indiana, South Bend Division.

  • Couple Filed Biomet Lawsuit Alleging Device Caused Hip Replacement InjuriesMay 2016 – Topeka Kansas couple have filed a lawsuit against Zimmer-Biomet claiming the product is defective. Lawsuit documents reveal that the female plaintiff underwent a Biomet hip replacement system procedure in January 2009 to replace both hip joints using the metal on metal devices. However, after her surgery, the plaintiff alleges she suffered severe pain that ultimately required two revision surgeries at the beginning of 2015 to replace both of her metal on metal hip devices.

    Lawsuit documents reveal that doctors noted there was soft tissue surrounding her hip joints and she had been diagnosed with chromium/cobalt ion poisoning and metallosis. This case is filed in the U.S. District Court for the Northern District of Indiana, South Bend Division.

Hiring a Biomet Hip Replacement Injury Attorney

The artificial hip replacement injury attorneys at the Drug Law Center are currently reviewing and accepting cases on behalf of our clients who have suffered harm after undergoing a Biomet hip replacement surgery. With our years of experience and access to valuable resources, we can streamline the process of successfully resolving cases involving defective implant devices.

If you, or a loved one, believe your adverse side effects were caused by a Biomet hip implant device, contact us today to discuss your case through a comprehensive, case evaluation at no charge to you. We are currently postponing payment of our legal services until after we have successfully resolved your case by negotiating an out-of-court settlement on your behalf or winning your case in front of a judge and jury.

Sources:

https://www.fda.gov/AdvisoryCommittees/ucm297884.htm

https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm

http://www.reuters.com/article/us-biomet-settlement-idUSBREA1305Y20140204