DePuy's Pinnacle Replacement Hips
Unlike DePuy's ASR replacement hips, the Pinnacle replacement hips manufactured by DePuy have not been recalled. However, like the DePuy ASR, Pinnacle hip replacement solutions includes a metal-on-metal replacement joint that some recipients allege has some of the same faults as the ASR. Some interesting facts:
- Pinnacle & ASR are both DePuy artifical hips
- Both manufactuered by Johnson & Johnson subsidiary DePuy, Pinnacle hip solutions, released in 2002, was the predecessor to the ASR (released in 2005). Both ASR devices (resurfacing and total hip) are metal-on-metal; Pinnacle hips can be metal-on-metal, ceramic-on-polyethylene, or metal-on-polyethylene.
- Pinnacle even more used than ASR
- Nearly 150,000 Pinnacle hips have been implanted compared with 93,000 ASR hips worldwide.
- Approved through same FDA "loophole"
- Like the ASR, the Pinnacle was approved through the FDA's 501(k) approval process, which lacks requirements such as clinical trials.
- Complaints to the FDA
- Nearly 1300 complaints have been lodged with the FDA about DePuy's Pinnacle artifical hip devices between the start of 2011 and September 30, 2011. In that same time, 500 complaints have been recorded with the FDA regarding the ASR replacement hips.
- Cobalt Chrome: metal debris injuries and the Ultamet
- High blood cobalt levels in ASR patients can indicate serious damage to the hip and groin and systemic problems resulting from metal ions spread through the bloodstream. Designed for use with the Pinnacle hip system, DePuy's Ultamet metal-on-metal articulation system is made from cobalt chrome and many patients assert they are suffering from the same ill effects from metal leaching off the device as ASR patients.
Many patients believe it is causing them some of the same issues ASR patients are suffering from, including tissue and bone damage, fractures, disclocation, metal debris injuries, psuedotumors, and premature joint failure.
Do you have a Pinnacle or ASR hip replacement system implanted? Are you having problems with your metal-on-metal hip? Contact your doctor, surgeon, or the hospital where you had your surgery if you are concerned about the type of device you have installed or believe your implant is causing you problems. Even symptom-free metal-on-metal devices may require more frequent follow up than other replacement hips.
For questions about legal recourse available if you were wrongly injured by a medical device, please contact us today. There are no fees, costs, or obligations associated with speaking with one of our attorneys. There are, however, statutes of limitations that can prevent you from protecting your rights.
Every case is unique and yours is no exception, contact us today to find out out we can help you.
- MAUDE (Manufacturer and User Facility Device Experience). FDA Medical Devices Databases. <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm> Accessed 11/1/2011.
The ASR may have made it to market through a loophool, but how did it stay on the market? Between medical device registries, regulatory agencies, and active surgeons, plenty of red flags were raised. [History of the ASR]
Metallosis, metal debris injuries, metal ion levels, ALVAL: known by a host of names and associated with a wide variety of symptoms, the damage metal from replacement hips can cause can be catastrophic. Learn more about high cobalt levels from hip replacements.
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