Flawed Hip Replacement Hardware Prompts Spike in Recalls and Malpractice Litigation

By | June 7, 2017

In a 2015 statement by Dr. Mark Pagnano, the chairman of orthopedic surgery at the Mayo Clinic (Rochester, Minnesota), the number of hip replacements performed in the United States has skyrocketed in recent years.   While many believe this to be a result of the aging population, with more than 46.2 million seniors over the age of 65 in America, Pagnano revealed that increasingly younger patients need the surgical procedure.

Hospital statistics revealed that from 2000 to 2010, individuals over the age of 45 years accounted for 95% of hip replacement surgeries.   The number of hip replacements more than doubled from 138,700 to 310,800 in a decade.  To explain why there has been an increase in the need for hip replacement surgeries, the U.S. National Center for Health Statistics (NCHS) revealed that osteoarthritis diagnoses are increasing among all age groups.  Increased domestic obesity rates are also a factor, however some experts imply that America’s healthy change to promoting increased fitness and athleticism is having a downside, as ‘wear and tear’ on joints is becoming a factor for younger patients.

Unfortunately, aligned with the increased rate of osteoarthritis and hip replacement surgeries (under the age of 65 years), is a recent problem with the manufactured quality of ball joints and parts used for the replacement surgery.  Recalls and litigation, as well as malpractice and class action suits have named some of the world’s largest medical hardware manufacturers in sizeable settlements. We will share an example of the impact of faulty hardware for victims, and some of the details regarding hip replacement hardware litigation and plaintiff awards.

Understanding Hip Replacement Surgery and Hardware Problems

The surgery to remove the structure around the hip, and replace it with plastic, metal or ceramic components, is a highly invasive surgical procedure, but one that has a tremendous success rate.  Replacing natural bone with a man-made material however, has proven to provide some serious health implications and risks for patients.

The hip capsule (where the two pieces connect) can degenerate over time, due to regular wear and tear, and normal cartilage (the padding between the acetabulum and femoral head) wears down and is eventually destroyed.  During a hip replacement surgery, if the cartilage is damaged, it can be removed, and the femoral head is often smoothed to remove bone spurs, which are the leading cause of pain for patients prior to surgery.

Metal on Metal (MoM) hip replacements are frequently selected because they are more durable than other types of materials, and potentially less toxic than plastic polyethylene options.  Unfortunately, the friction that is created between the acetabulum (socket) and the femoral head (ball joint shaped bone that rests inside the socket) can produce metal fragments (metallosis) that can travel to other areas of the body, including the heart and lungs.  The metal ‘dust’ is also responsible for allergic reactions causing swelling around the hip, and osteolysis (further degeneration of other bone tissue in the immediate area around the replacement hardware).

During installation of hip replacement components, the metal stem that replaces the femoral head is removed, and it is cemented to secure it into the bone.  Because osteoarthritis causes bone to weaken and wear down, metal fasteners can also be installed to secure the MoM hardware to help prevent hip dislocation. A spacer is installed in place of the cartilage, which can be made from plastic, metal or ceramic materials to help cushion and insulate the acetabulum (ball joint), and to promote smooth movement and gliding within the socket.  Unfortunately, these insular materials can also wear down over time, creating friction and pain for the patient.

The most significant and reoccurring issues with hip replacement software include:

  • Misalignment of implants, which impacts gait and pressure on the pelvis bone by ineffectively

        distributing body weight.  

  • Leg length differential (LLD), where the implant is incorrectly installed and pulls one leg higher than the other.
  • Infection.  Installation of any foreign hardware that is not sterile into the body, can lead to serious bone infections and health risks.
  • Loosening from the bone.  Over time, implant hardware can become unfastened to the natural bone, and shift painfully inside the body, making bending and weight bearing difficult.
  • Blood clots are an immediate risk after the major surgery, and they can lead to a heart attack or stroke in patients, days or weeks after the procedure.
  • ·Noisy hardware.  A fitting problem or hardware failure can result in a squeak or grinding sound for the patient, any time they pivot, bend, or sit.

There are two tiers of malpractice liability regarding hip replacement surgery.  The first and most common, is malpractice allegations against the care provider and surgical team for negligence while installing the hardware.   The second cause is from manufacturers who provide faulty hip replacement hardware; an occurrence that is happening with more frequency, resulting in extensive litigation and awards for victims.

Stryker Rejuvenate and ABG II Hip Replacement Settlement

The New Jersey Plaintiff Settlement Committee outlined the terms for the Stryker Master Settlement Agreement and general terms for those who received a faulty hip replacement product from the manufacturer.   The settlement agreement came after a global recall of the ABG II Hip Replacement product, which allegedly caused surgical complications due to device failure.

The court ordered unlimited fund seeks to compensate thousands of individuals who received a faulty ABG II Hip Replacement, and provides an estimated $300,000 base award for each plaintiff.   The total anticipated settlement may exceed over $1 billion dollars (USD).

DePuy ASR And Pinnacle Hip Replacement Litigation

A total of 9,939 lawsuits were filed against DePuy ASR (located in Ohio, Maryland) and 1,480 plaintiff suits were still pending in 2016.  The $4 billion-dollar settlement follows a global recall of the ASR Hip Implant hardware.   Despite the legal trouble, DePuy continues to sell the same model design almost four years after issuing the recall.

The metal on metal (MoM) hip replacement product resulted in serious and nearly fatal complications and damages to patients, as the device began to wear down quickly after implantation.   On average, plaintiffs saw degeneration of the medical grade hardware ten years earlier than the promised duration of usability, causing discomfort, and financial burdens on patients who were forced to seek a second, early hip replacement surgery to correct the problems with the device and components.

The manufacturers are two of the largest and best known hip replacement hardware providers, but there are many more including the Wright Porfemur-Z Hip System and the Zimmer Durom Cup that are engaged in class action and liability suits regarding hardware malfunction. Clients should be informed of the manufactures named, and should pursue both documentation and legal consultation if they feel they have been the victim of malfunctioning hip replacement hardware.

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