History and Background of Zimmer Biomet

Zimmer Biomet was established by its founder Justin Zimmer in Warsaw, Indiana, in 1927, to manufacture aluminum splints.  Zimmer’s take on the medical devices grew in popularity and by 1942, the company’s annual sales reached $1 million. In 1950, Zimmer introduced the company’s first hip prosthesis in association with Dr. Palmer Eicher, and in 1972 the company was acquired by pharmaceutical and medical device behemoth, Bristol Myers Squibb. In 2001, Zimmer was spun off by Bristol Myers Squibb as a free-standing public company and in 2014, Zimmer paid $13.4 billion to acquire Biomet, Inc., in the process forming today’s Zimmer Biomet.

Among the range of products Zimmer Biomet manufactures and markets across its divisions, its total hip replacement systems are some of the most prominently featured.  Zimmer Biomet’s hip replacement systems include the following brands:

• Taperloc Hip System
• Zimmer M/L Taper Hip Prosthesis
• Arcos Modular Hip System
• Continuum Acetabular System
• G7 Acetabular System

Issues with Zimmer Biomet Hip Implant Technologies and Implant Lines

Zimmer Biomet pushed the M/L Taper line with Kinectiv Technology through the 510(k) Clearance process which does not require that the device go through the rigors of a clinical study to gain approval by the U.S. Food and Drug Administration (FDA).  The M/L Taper Line with Kinectiv Technology made it onto the market in March 2015 and remained there briefly, until  April 2015 when it was removed.  In May 2018, Zimmer Biomet sent an “Urgent Medical Device Recall Letter” to hospitals, physicians, and distributors and in June 2018, the U.S. Food and Drug Administration issued a Class I recall of the M/L Taper with Kinectiv Technology for 64 lots (752 devices in total) due to higher than allowed cytotoxicity levels found within the product.  In 2018, the FDA issued a subsequent Class II recall notice concerning packaging issues involving telltale “black residue” emerging within the polyethylene bags containing implant devices.

Several lawsuits have been filed over the Zimmer Biomet M/L Taper Line with Kinectiv Technology and these have been consolidated into a single MDL before a federal court in Indiana. Claimants in these suits allege, among other things, that the modular neck-stem design creates threading and several junctures where the metal head is more likely to produce wear and debris in a process known as “fretting”.  In turn, the corrosion and wear from the fretting are believed to have caused severe tissue damage and even metallosis in implantees.  These conditions require patients to undergo painful and expensive revision surgeries that do not always completely resolve either the complications of the original underlying condition.

Tracy Everhart

Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.