DePuy Pinnacle Hip Implant
Use of the DePuy Pinnacle metal-on-metal hip implant (Pinnacle MoM implant) has been linked to serious complications, including implant loosening and failure, and the release of metal particles into the surrounding tissue. These complications can lead to extensive damage to bone, muscle, and nerves, which often require hospitalization and additional surgeries to replace the original device.
What Is The Pinnacle MoM Hip Implant?
The Pinnacle MoM implant is an artificial hip implant used to replace a patient’s diseased hip joint. The implant consists of a shell implanted into the hip socket, a metal liner inserted in the shell and a metal “head” that connects to the upper part of the leg.
Pinnacle MoM implants are manufactured by DePuy Orthopedics, Inc., a subsidiary of Johnson & Johnson. The Pinnacle MoM line of implants was launched in 2001, and these devices have been implanted in hundreds of thousands of patients since then.
The FDA cleared the use of Pinnacle MoM implants for total hip replacement. This procedure is indicated when the hip joint is severely painful or disabled (from arthritis or congenital hip dysplasia), the components of the hip joint are fractured or damaged, or previous hip surgeries have failed to alleviate the problem experienced by the patient.
DePuy discontinued the Pinnacle MoM implant in 2013. Three years earlier, in 2010, DePuy had discontinued another MoM hip implant with many similarities to the Pinnacle MOM implant – the ASR hip implant. The ASR hip implant had a very high rate of premature device failure.
When they were first introduced to the market, MoM hip implants such as the Pinnacle MoM implant were touted by device manufacturers as an orthopedic innovation. Many orthopedic surgeons chose MoM implants for their perceived potential to accommodate younger, more active patients and reduce the incidence of implant dislocation. But since their introduction, data shows that MoM devices have not reduced the likelihood of this serious complication, but have created a higher likelihood of other complications, and their use has fallen off significantly.
Thousands of patients have experienced adverse health consequences from the Pinnacle MoM implant, including:
- damage to bone and tissue surrounding the implant
- nerve damage
- implant dislocation
- implant corrosion
- implant failure
These are serious complications, often requiring hospitalization and revision surgery to replace the original implant. In certain cases, the complications lead to crippling injuries, which the revision surgery cannot fix.
In 2011, due to the high number of reports of complications resulting from the use of MoM hip implants, the FDA ordered the manufacturers of these devices – including DePuy – to undertake follow-up studies of patients implanted with their MoM hip implants.
The FDA and its counterparts in other countries have also published multiple alerts and safety communications warning about concerns with MoM hip implants. The FDA recommends that patients without symptoms “continue to follow-up with their orthopedic surgeon every 1 to 2 years to monitor for early signs of change in hip status.” It also cautions that symptoms of a device breakdown may not be hip-related because the breakdown of the MoM hip implant sends metal ions into the bloodstream, creating systemic symptoms such as skin rashes, neurological and psychological changes, and kidney impairment.
Complications and Long-Term Risks
The Pinnacle MoM implant is known to be at risk of premature failure and dislocation. In addition, as the metal parts of the implant rub against each other, they release metal particles, which create additional health hazards. These complications may lead to severe and potentially crippling health problems, including bone, tissue, and nerve damage. The FDA recommends that even those MoM hip implant patients who do not exhibit symptoms remain under the monitoring of a physician to detect the early signs of implant failure.
Implant failure may also be accompanied by the release of metal ions into the bloodstream. Therefore, the FDA recommends that patients monitor their general health for symptoms consistent with elevated metal ion levels, which can be an indicator that their implant is failing. These symptoms include:
- General hypersensitivity reaction (skin rash)
- Neurological changes including sensory changes (auditory, or visual impairments)
- Psychological status change (including depression or cognitive impairment)
- Renal function impairment
- Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold)
FDA Safety Warnings
Although the FDA has not banned or recalled MoM hip implants, it has raised significant concerns about this type of devices.
- In May 2011, the FDA issued an unusual order to MoM hip implant manufacturers to conduct post-market surveillance studies on patients implanted with the manufacturers’ devices.
- In January 2013, the FDA issued a Safety Communication about MoM hip implants. It recommends that orthopedic surgeons select MoM implants “only after determining that the benefit-risk profile of using a metal-on-metal hip implant outweighs that of using an alternative hip system (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic or ceramic-on-metal).” The FDA also urges physicians to be aware of systemic symptoms of metal ions in the bloodstream as a possible indicator of implant failure, and notes that patients “who develop any symptoms or physical findings that indicate their device may not be functioning properly, should be considered for metal ion testing.”
- The FDA published a webpage titled “Concerns about Metal-on-Metal Hip Implants” (last revised on April 10, 2015), in which it summarizes the potential complications and symptoms of device failure, and provides guidance regarding patient monitoring. On this page, the FDA also notes that its counterparts in other countries have issued alerts and safety communications about MoM implants as well.
- In February 2016, the FDA issued a final order requiring MoM hip implant manufacturers to submit a premarket approval application after determining that these implants should remain categorized as Class III (higher risk) devices.
Thousands of lawsuits have been filed in the United States against Johnson & Johnson and DePuy. These lawsuits seek compensation for complications and injuries associated with the implantation of the Pinnacle MoM implant. To date, four trials have been held, and in three of these trials the jury found Johnson & Johnson and DePuy liable for the harm suffered by the plaintiffs.
How We Can Help
If you have suffered serious health problems after being implanted with a Pinnacle MoM implant, or if your doctor has advised you that you need special monitoring or care to make sure that a Pinnacle MoM implant does not cause complications in the future, you may be entitled to reimbursement for medical expenses, lost wages and other costs. Attorneys at Wilentz, Goldman & Spitzer P.A. may be able to help you recover compensation if you suffered serious harm from a Pinnacle MoM implant. As a nationally recognized personal injury law firm, Wilentz is committed to helping clients with their cases.
For a free consultation or more information about your legal options, please call the number below. Or, if you prefer to complete our free case evaluation form, our client relations representative will contact you shortly.