Stryker Hit with First Lawsuit After Rejuvenate Hip Implant RecallAug 10, 2012 | Parker Waichman LLP
A Florida woman has reportedly become the first in America to file a lawsuit against Styrker Corp. over defects with its Rejuvenate metal hip component. She claims the device caused her severe pain within months of being implanted with it last Fall.
According to a report from The (North Jersey) Record newspaper, the 66-year-old woman was fitted with the since-recalled Rejuvenate device in an October 2011 procedure. Within months, reports of pain at the site of the implant prompted an X-ray.
The Rejuvenate is like other metal-on-metal hip implants and their component parts in that it was supposed to have a lifespan close to two decades. Instead, this woman like thousands more across the country and even more across the world suffered complications caused by a defective implant often within two years of receiving it.
Though the device was in place, tests showed that elevated cobalt and chromium levels were causing more serious damage in the Florida woman’s case. A surgery was conducted shortly thereafter just two months ago in which doctors removed abnormal tissue growth around the site of the Rejuvenate implant. The surgery also aimed to remove the implant but in the process, the woman’s femur bone was fractured, requiring an additional procedure to repair that error.
She has since endured more procedures to correct other complications caused by the initial two surgeries and has once dislocated her hip. She’s now receiving temporary care at a nursing home while she recovers from those procedures.
The woman has filed a lawsuit against Stryker Corp., which has since recalled the Rejuvenate and several other metal-on-metal hip implant components, claiming the company knowingly manufactured and sold a defective medical device.
Stryker issued the recall recently on four hip implant components that comprise all-metal replacement joints. The reason stated for the recall was the risk of “fretting and corrosion” caused by the metal components contacting each other.
The Stryker recall was issued after the Food and Drug Administration ordered makers of all-metal hip implants and implant component parts to conduct full post-market safety testing to prove they’re as safe as first purported to be when they gained agency approval. The Rejuvenate device was only approved in 2010 and like several others, and probably more in the months and years ago, will make a quick exit.
A lack of pre-market safety testing likely led to thousands of avoidable injuries to recipients of the devices. Repeat surgeries like those endured by the Florida woman who has filed this lawsuit decrease the likelihood of ever regaining full mobility from the affected hip joint and the risk of injury increases with each procedure.