FDA Examines Zimmer Hip Replacement Problems
The Federal Drug Administration (FDA) is addressing an increasing number of complaints regarding Zimmer hip replacement problems. Some Zimmer Durom Cup users allege that the hip implant device leads to early hip replacement surgery, hip failure and elevated levels of chromium and cobalt in tissues and the blood stream.
This year, the FDA has received more than 5,000 complaints related to metal-on-metal hip implant devices, which include the Zimmer Durom Cup, a metal on metal device that was temporarily suspended in 2008 due to Zimmer hip replacement problems. The product is back on the market and causing some users to seek a Zimmer hip lawyer.
Common Problems Associated with Zimmer Hip Replacements
Zimmer Inc. halted the sale of its most popular hip implant device, the Zimmer Durom Cup, 2008 because the metal-on-metal device was causing excessive Zimmer hip replacement problems, including migration.
The Zimmer Durom Cup would shift on the hipbone, causing the component to loosen or dislocate. While the company felt it resolved some Zimmer hip replacement problems related to the Durom Cup in 2008, metal on metal implant devices can cause metallosis or metal poisoning and users are at risk of both.
Metallosis and Zimmer Systems
Zimmer metal on metal implant devices can release metallic particles into surrounding tissues and the user’s bloodstream leading to metallosis. Metallosis can be painful and result in the removal of the implant and hip revision surgery.
Though metallosis is one of several Zimmer hip replacement problems, Zimmer Inc. isn’t facing the volume of metallosis-related lawsuits faced by DePuy, a subsidiary of Johnson & Johnson. DePuy’s system has been found to shed dangerous metal particles into the blood stream and has since resulted in thousands of lawsuits.
It’s likely that Zimmer Inc. avoided lawsuits associated with major Zimmer hip replacement problems like metallosis when it temporarily pulled the product in 2008.
Issues concerning the effectiveness of these metal on metal hip implants has prompted the FDA to ask 21 orthopedic device manufacturers to outline how they will monitor the effectiveness of the devices after surgery. It could take up to a year before these plans are handed over to the FDA.
The submissions will hopefully aid in Zimmer hip mediation.