Problems with the DePuy Pinnacle Hip Implant: Current Reports

As of this date the Pinnacle metal-on-metal hip implant device manufactured by DePuy has not followed in the recall footsteps of DePuy’s other hip implant, the ASR. While Johnson and Johnson and DePuy vigorously deny that the Pinnacle has any problems—and, in fact, call it the best metal-on-metal hip implant on the market today—many recipients of the device feel it has some of the same flaws as the ASR. Both the Pinnacle and the ASR are manufactured by Johnson and Johnson’s subsidiary company, DePuy. The Pinnacle made its debut in 2002 as the predecessor of the ASR which followed in 2005. The ASR is strictly a metal-on-metal hip implant device while the Pinnacle name includes metal-on-ceramic and metal on polyethylene models as well.

Nearly 150,000 Pinnacle all-metal hip replacements have been implanted compared to 93,000 ASR’s worldwide—approximately half of those in the United States alone. Both the Pinnacle and the ASR all-metal hip implants were approved under the controversial 510(k) FDA approval process. This particular process allows the majority of medical devices to get to market quickly by showing they are substantially comparable to a device which has already gained approval. The process also allows a product to get to market without expensive clinical trials however in some cases the approval process has been predicated on a device which is no longer marketed—even due to poor performance.

Between the beginning of 2011 and September 30, 2011 some 1300 complaints have been lodged with the FDA regarding the Pinnacle, and 500 for the ASR. While the failure rate of the Pinnacle does not appear to be nearly the rate of the ASR, it does share the same potential for metal toxicity as the ASR. When the metal acetabular cup and ball—both made of cobalt and chromium—rub against one another during the recipient’s activity the friction which results causes tiny metal ions to shear off. These ions may either lodge in nearby muscle tissue, eventually causing those muscles to decay, or could find their way to the bloodstream where they can be responsible for a myriad of symptoms from relatively minor to extremely severe.

Physicians of ASR patients have documented serious negative health effects in the cardiovascular, kidney, neurological and thyroid systems. While there has been no hard data regarding cancer risk, patients with high levels of cobalt and chromium in their bloodstream have noted extreme pain, degeneration of muscle tissue, vision disturbances (and in some extreme cases, blindness) hearing problems, balance and coordination issues, skin disorders, an inability to distinguish between sweet and salty foods and memory loss. In the end the Pinnacle has the same cobalt and chromium risks as the ASR even though it may not be constructed with the exact same science.

Whether a patient is implanted with an ASR or a Pinnacle device it is likely that chromium and cobalt are shedding into the body causing metallosis, necrosis and bone loss. Muscles behind the femoral head can be lost forever due to the shedding metal ions and that muscle can never be regained. You can certainly make the surrounding muscles stronger through exercise, but muscle does not regenerate. This means that a recipient may begin to walk with a gait which then turns into a limp, then soon they are using a cane, a walker, a scooter—and finally they are left sitting in a chair, unable to walk and in constant pain. DePuy claims their Pinnacle device has a smaller head which minimizes the friction between the metal parts and are taking a hard line in its defense.

DePuy executives place the failure rate of the Pinnacle at 4-4.5% within five years which is well within acceptable limits. Remember, however, that DePuy claimed the ASR had a failure rate of approximately 12% when it was recalled, however later studies show that the ASR has a 49% failure rate at 6 years and a whopping 80% at eight years. Although the FDA ordered all metal-on-metal hip implant manufacturers to conduct follow-up studies on all cases in which an implant failure led to serious consequences, less than a quarter of the study plans have been finalized—including DePuy’s.

Andrew Sullo, Managing Partner and Class Action Lead Counsel of Sullo & Sullo, LLP believes that the Pinnacle litigation will run approximately 12-18 months behind the ASR litigation and that the hundreds of boxes off discovery provided in the ASR lawsuits will be identical in many ways to the upcoming Pinnacle discovery. Because Pinnacle recipients may well end up with many of the same negative health effects as ASR recipients, those with either device should seek qualified legal advice and assistance. Sullo wants all Pinnacle and ASR clients to know that “Sullo & Sullo currently has dozens of DePuy ASR and Pinnacle clients,” and that the highly qualified Sullo attorneys will work hard to ensure all recipients of metal hip implants are fully protected.