Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more
In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more
Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more
Exactech has recalled hundreds of thousands of implantable ankle, knee, hip and shoulder replacement devices over the past few years. If you or a loved one received an Exactech implant in 2004 or later, it will be important...more
Robins Kaplan LLP is examining the recent recall of orthopedic devices that were manufactured by Exactech for hip, knee, and ankle implants. Since 2021, Exactech has recalled approximately 185,000 devices with the latest...more
On February 20, 2020, CMS released a proposed rule that would extend the bundled-payment model for joint replacement surgery for an additional three years and broaden its scope to include outpatient procedures (the Proposed...more
DUSTING SPRAY DEATHS AND INJURIES - Robins Kaplan LLP is investigating and litigating “dusting” cases, which arise when someone inhales—or “huffs”—compressed gas dusting spray for its intoxicating effects while driving and...more
In what has become an alarming trend in drug and medical device manufacturing, Smith and Nephew felt compelled to copycat other hip implant manufacturers and market a pair of dual modular hip stems. This trend is alarming...more
Searcy Denney is representing clients who have been implanted with the Short Modular Femoral Hip System and Modular REDAPT from Smith & Nephew in lawsuits alleging that the manufacturer failed to warn them of the risks...more
DePuy Synthes, a part of the Johnson & Johnson Medical Devices Companies, announced recently that it has signed a definitive agreement to acquire the assets of Medical Enterprises Distribution, LLC, which includes the...more
The Third Circuit has become the first U.S. Court of Appeals to address the application of the express preemption provision in the Medical Device Amendments of 1976 to hybrid medical devices. Hybrid medical devices are...more
In the January 11, 2018 issue of MLN Connects, CMS has now widely publicized that it issued billing guidance for major joint replacements (hip or knee) in May 2017 at ICN909065. CMS reports that major joint replacement is...more
OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more
For over four years I have been investigating problems associated with Stryker Accolade TMZF Titanium hip stems. Of course the Rejuvenate and ABG II failures and subsequent recall are well-known and much written about. But,...more
As a medical device lawyer for more than 20 years, I have received so many calls from patients who are concerned that they have a recalled hip implant in their body. Often, their first notice of a potential problem with their...more
Stryker Accolade V40 LFIT Hip Implant Dissociation - Over the past few years, various orthopedic surgeons around the country and their patients have faced a catastrophic failure of Stryker’s Accolade and V40 LFIT hip...more
Stryker V40 Femoral Heads (CoCr) Associated With Spontaneous and Catastrophic Head-Neck Dissociation - Stryker may face yet another crisis associated with their total hip replacement medical devices – and this time it...more
On September 27, 2016, the Department of Health Therapeutic Goods Administration (the Australian equivalent of the Food & Drug Administration) issued a hazard alert relating to LFIT Anatomic CoCr V40 femoral heads...more
OMB Reviewing Final Rule Regarding New Payment Model for Hip and Knee Replacements – The White House Office of Management and Budget (OMB) received for review on October 28, 2015, a final rule establishing a new Medicare...more
Johnson & Johnson (J&J) has requested that an $8.3 million judgment against the company over its DePuy metal-on-metal (MoM) hip implant be put on hold....more
Ok, excuse that bad joke. But the recent decision in In re: Biomet, the hip replacement multi-district litigation out of the Northern District of Indiana, is noteworthy because it discusses proportionality and predictive...more