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Zimmer develops orthopedic implants and other surgical products. Recently, components in one of its knee implants have been called into question for loosening.
In 2012, medical device manufacturer Zimmer introduced its Persona Personalized Knee Replacement System.The company said it was to “provide the best fit” for individuals looking for a joint that felt natural and allowed them to fully engage in their regular activities.
Zimmer has voluntarily recalled more than 11,500 porous coated, uncemented Zimmer Persona Trabecular Metal Tibial Plates. The defective component is concerning because it may potentially become loose. Loosening was diagnosed clinically and by X-ray findings of “lucencies.”
The company has also voluntarily recalled the Zimmer Persona Tibial Articular Surface Provisional (TASP) Shim tool. The TASP ball bearings from the tool may be left in the surgical wound, may delay surgery, or may be ejected during surgery. These problems are believed to be caused by the ball bearing retention component of the tool, known as the “swage,” which can break down after sonic cleaning.
The recall sought to notify distributors and hospitals with affected inventory that to prevent this problem, the shim tool needs to be manually cleaned and inspected. Revised instructions were provided.
The FDA has designated these voluntary recalls as Class II recalls. This means that a medical device may cause “adverse health consequences.”
There were 11,658 of the porous coated, uncemented Zimmer Persona Trabecular Metal Plates recalled from around the world, including the following states in the United States: Alaska, Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin. The notice states that “All affected product are to be located and quarantined immediately.”
A total of more than 67,000 Zimmer Persona Tibial Articular Surface Provisional Shim tools were recalled from around the world, and nationwide in the U.S., including Washington D.C. and Puerto Rico. Zimmer noted that these shims must be “manually cleaned and inspected” in the recall.
As a result of a Freedom of Information Act request submitted to the FDA, W&L was able to discover that the FDA had concerns about certain Zimmer Persona knee components which the FDA repetitively communicated to Zimmer prior to the initiation of these above-mentioned recalls.
After a spring 2014 FDA inspection of a Zimmer facility, FDA inspectors called attention to “objectionable conditions” and reminded Zimmer that by law “your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the quality system requirements.” Zimmer had received several complaints of fractures in tools where the TASP shim tool was used from March 15 through May 28, 2014.
The FDA noted that Zimmer, in a Field Action Authorization Form approved internally by Zimmer on January 29, 2014, stated that “the immediate health consequence which may result from use of or exposure to the TASP is minor surgical delay and possibility of fragment retention such that the probability of serious adverse health consequence is less than remote.”
Although the seriousness was deemed “less than remote,” the FDA noted in its inspection that “[a]ccording to your firm’s [Zimmer’s] clinical personnel, the effect on the patient from surgical delay may be blood loss or prolonged exposure to anesthesia such that the chance of these complications occurring increases if the patient has other comorbidities (strong cardiac or respiratory history, morbid obesity, etc.).” The FDA inspectors found that “these factors were not documented in [Zimmer’s required] HHE [Health Hazard Evaluation]…” The potential delay in surgery problem was cited in the voluntary TASP recall made several months later.
The FDA investigators also noted that “acceptance criteria was not met for the design validation of your [Zimmer’s] Class II Persona Knee 14x +30mm Tapered Tibial Stem Extension and respective Persona Knee 14x +30mm Drill executed under the Design Validation Protocol…” The investigators cite as an example the question “Was there any damage to the soft tissue or bone caused by the drill that is not clinically acceptable?” which was answered “yes,” was not addressed in the Design Validation Report.
Like many forms of surgery, knee replacement surgery is not without risks. Complications following initial knee replacement surgery and following revision (follow-up surgery to correct an earlier procedure) surgery are similar and can include:
If you have had a porous coated, uncemented Zimmer Persona Trabecular Metal Tibial Plate implanted or a knee surgery that used a Persona Tibial Articular Surface Provisional shim tool and are experiencing pain which may suggest loosening of your device or other problems, you should consult with your doctor. If you are having problems, consider contacting an attorney.
As a nationally recognized personal injury law firm, Weitz & Luxenberg is committed to helping clients win cases. For more than 25 years, we have dedicated ourselves to holding irresponsible manufacturers accountable, and we have won $17 billion for our clients.
We are in the forefront of orthopedic medical device litigation, with one of our attorneys serving in court-appointed Lead Counsel roles, managing the steering committees of litigations involving recalled hip implants. In that capacity, Weitz & Luxenberg played key roles in negotiating settlements in excess of $5 billion for clients who needed to have those hip implants revised.
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