Will Failure Rate Reports Lead to Zimmer Hip Recall?
In response to calls for a Zimmer hip recall, the artificial hip maker chose in 2008 only to issue a brief suspension of sales, during which time it re-packaged its controversial Durom Cup implant with new and more detailed surgical instructions. Zimmer hip lawsuits brought on by Zimmer hip lawyers have continued to mount, however, even after the Durom Cup model’s re-emergence onto the market. Is a comprehensive Zimmer hip recall on the horizon?
Metal-on-Metal Durom Cup the source of complications
The FDA did not require any clinical trials before approving the Zimmer Durom Cup hip replacement system for the market in 2006. The Durom Cup model is a metal-on-metal prosthetic device that dispenses with the use of cementing glues, and instead relies on a physiological process by which natural bone merges with the artificial metal parts. The Durom Cup model is considered a highly advanced prosthetic that can provide recipients with the opportunity to live an active lifestyle approximating that which they had before their hip problems.
Petitions for a Zimmer hip recall followed quickly on the heels of the problematic device’s emergence on the market. While the FDA remained silent, many patients hired a Zimmer hip lawyer and filed Zimmer hip lawsuits after experiencing side effects such as inflammation, soft tissue infection, immobility, metal poisoning, implant dislocation and revision surgery.
Zimmer’s voluntary and temporary suspension of Durom Cup hip sales in 2008 was partially in response to a study that reported total device failure in up to 8% of implant recipients. Still, the FDA not only refused to issue a Zimmer hip recall, it took no formal action whatsoever.
FDA mandated report on Zimmer Hip failures
It was not until earlier this year that the FDA finally intervened in the Zimmer hip controversy. It has mandated that all orthopedic device manufacturers, including Zimmer, must provide in-depth data reports about the success and failure rates of their artificial hip systems, along with the rates at which each device requires replacement and revision surgery.
Many in the medical community speculate that this FDA mandate might be a first, preliminary step towards formally requesting a Zimmer hip recall. A Zimmer hip lawyer will be watching closely for the results of the FDA-requested data reports, which are set to be due from the hip makers later this year. If the implant failure rates prove to be as high as previous medical studies and individual patient testimony suggest, then an increase in the amount of Zimmer hip lawsuits will likely follow.