WASHINGTON, May 21, 2014 /PRNewswire/ -- The US Drug Watchdog, a consumer advocacy group created to help raise awareness of faulty medical devices and potentially dangerous pharmaceuticals, has urged all recipients of a DePuy Pinnacle hip implant to contact their toll-free number as soon as possible. Recipients of this model of hip implant may be at risk for toxicity in the blood and the need for a hip implant replacement, and as they would like to explain a simple blood test can help people determine whether they are at risk for premature failure of their all-metal hip implant.
"Launched in 2001, DePuy's Pinnacle hip replacement system targeted younger, more active patients with marketing claims that it could withstand an active lifestyle. Over 140,000 US citizens have received the Pinnacle all-metal hip implant device. However, thousands of patients have entered class action lawsuits due to serious complications stemming from the replacement hips, including implant failure requiring revision surgery as well as toxicity from metal debris in the blood," the US Drug Watchdog said. For more information recipients of a DePuy Pinnacle hip implant are urged to contact the US Drug Watchdog anytime at 866-714-6466.
Although a recall for the Pinnacle system was never issued, DePuy announced they would be pulling the Pinnacle system, as well as other products that used the same metal-on-metal components, from distribution in August of 2013. This decision followed an order from the FDA for all metal-on-metal hip replacement manufacturers to conduct post-market follow-up testing for safety and efficacy.
Some of the complications stemming from this type of hip implant, including the Pinnacle system, include a loosening or complete detachment of the implant from the hip bone, which can then lead to bone fracture or dislocation.
Additionally, high levels of metal toxicity have also been reported in Pinnacle patients. Due to friction between the metal parts, cobalt and chromium are leaked into the bloodstream. At high levels, this can lead to metallosis, a medical condition in which metal debris builds up in the soft tissue, leading to inflammation, cobalt poisoning, and other serious conditions.
Patients who have metal-on-metal hip implant failures often experience one or more of the following side effects:
- Pain in the hip region
- Inability to walk/difficulty walking
- Limited flexibility
- Swelling/inflammation in the hip region
In some cases, patients may experience tissue damage before the symptoms present themselves. According to a March 2013 study published in BMJ Open, elevated levels of metal ions in the blood are associated with early failure of metal-on-metal hip implants. The study's authors say the findings indicate that "blood metal ion tests can be used as a clinical indicator of the risk of early joint failure in asymptomatic patients."
For this reason, the US Drug Watchdog is urging anyone who has received a Pinnacle hip replacement system to contact them as soon as possible, even if they are not experiencing painful symptoms yet. "We want to make certain all DePuy Pinnacle hip implant recipients get help," says a US Drug Watchdog spokesperson. "We are urging recipients of this specific type of hip implant device to call us anytime at 866-714-6466 so we can provide them with as much useful information at possible, including information about a specific blood test that measure cobalt, and chromium in a recipients blood."
DePuy Pinnacle U.S. District Court for the Northern District of Texas MDL Number 2244
M. Thomas Martin
SOURCE US Drug Watchdog