The Stryker Hip Implant Recall and Its Effect on Implant Recipients

Stryker, a Michigan-based corporation, issued a Stryker hip implant recall in July, 2012. This Stryker hip implant recall came on the heels of an urgent field safety notification sent to hospitals and physicians in April, 2012. The notification as well as the Stryker hip implant recall stated a higher than normal risk of failure for the hip implants due to fretting and corrosion. Even though the Rejuvenate and ABGII hip implant devices use a ceramic ball, and are therefore not “true” metal-on-metal hip implants, they nonetheless are constructed of a cobalt and chromium neck, a titanium stem, and metal trunnions located on either end of the neck portion.

The metal neck juncture and the metal trunnions allow body fluids to become trapped, causing corrosion. The fretting and corrosion lead to tiny metal ions being sheared away from the device,
traveling to the bloodstream or lodging in surrounding hip tissues. When the ions burrow into hip tissue, the tissue will deteriorate and, in some cases, die. The metal ions cause inflammation, chronic pain for the implant recipient, possible infection, and bone loss. Total hip failure generally follows when the inflammation reaches sufficient levels.

All of these problems were directly responsible for the Stryker hip implant recall as well as the potential for metal poisoning among patients when the metal ions reach the bloodstream. The Stryker hip implant recall neglects to inform patients that no clinical trials and very few safety studies were done prior to the two implants receiving FDA approval. Under the 510(k) process, the manufacturer must only show that the proposed device is substantially similar to a device already on the market—even if that device has problems of its own.

The Stryker hip implant recall has resulted in lawsuits being filed across the United States, with many more expected. The Stryker hip implant recall left many recipients suffering serious health issues, huge medical expenses, lost wages, and chronic pain and suffering. Any person affected by the Stryker hip implant recall must first see a doctor and have their health taken care.  Further, without the help of a qualified, experienced Stryker hip implant recall attorney, many of the patients harmed by the Stryker hip implant recall may be unable to recover any of the financial losses they have suffered.