Who Is Zimmer?
Zimmer Biomet is a medical device company founded in 1927 in Warsaw, Indiana, as Zimmer, which was originally an aluminum splint manufacturing company. Over the subsequent decades, Zimmer gradually expanded its medical device products, including joint replacement devices such as knee replacements. In 2014, Zimmer acquired Biomet, another medical device company. The acquisition was under a lot of scrutiny in Europe due to concerns that it would violate European antitrust laws, but the merger was allowed to go through, resulting in the company becoming Zimmer Biomet.
What Is the Zimmer Persona Knee Replacement?
The Zimmer Persona Knee system was designed to more closely mimic the natural action of the knee. Like its predecessor, the NexGen knee replacement device, it was intended to be long lasting for a more active and younger demographic. It was approved in 2012 and a major component of the system required recall just three years later.
When Was the Zimmer Persona Knee Replacement Approved?
The Persona knee implant was approved in 2012, using the FDA’s 510(k) premarket authorization process which allows manufacturers to receive approval without having performed costly clinical trials on human subjects. Using the 510(k) process, the manufacturer may receive approval based on a new device’s similarity to an older device and consequently, the Zimmer Persona had not been tested in human subjects before it was released for public use.
What Problems Are There with the Zimmer Persona Knee Replacement?
By 2015, just three years after its approval, the FDA had received numerous reports of Persona joint device loosening and the development of radiolucent lines, indicating the device had become disconnected from the supporting bone. Premature loosening of joint replacement devices can also be called “early failure” and often results in a requirement for revision surgery.
On March 12, 2015, after numerous adverse event reports were filed with the FDA, the agency issued a Class II recall for the device, warning physicians and hospitals to discontinue using the device immediately. Unfortunately, according to the FDA 11,638 devices had already been implanted.
What Complications Occurred with the Zimmer Persona Knee Replacement?
Knee replacement devices of any type carry a number of side effects. This may include bruising, swelling, pain, and stiffness which generally go away after a period of time.
Side effects that are more severe and may be caused by device failure may include:
- Severe knee pain that gets worse over time
- Temporary or permanent blood vessel and nerve damage
- Damage to surrounding tissue caused by particle shedding from the device
- Bone fracture in the area surrounding the implant
- Device failure resulting in dislocation
If device failure or loosening occurs, the joint may become unstable and result in immobility. It can also cause injury or damage to surrounding tissue. In most cases of device failure or when complications occur, the device must be removed and replaced as part of a knee revision surgery.
What Is Revision Surgery?
Revision surgery is another surgery done to repair or replace a joint replacement. Knee replacement revision surgery is often more complex and requires a greater surgical time and recovery time. In some cases, may also require more than one surgery to repair and reconstruct damaged joint tissue or broken bones.
When Was the Zimmer Persona Knee Replacement Recalled?
On March 12, 2015, the U.S. Food and Drug Administration (FDA) issued a recall for the Zimmer Persona Trabecular Metal Tibial Plate knee implant. The Class II recall was issued after multiple complaints were filed regarding “radiolucent lines” seen on exam and loosening of the devices.
What Is a Class II Recall?
Class II recalls are issued when it is discovered that a device may potentially cause a temporary or reversible medical or health threat. Persona’s joint loosening and radiolucent line development may be considered “reversible” if revision surgery is performed to remove and replace the faulty device. If device failure is not caught early enough, serious complications may result.
Who Was Impacted by the Zimmer Persona Recall?
The recall affected 11,638 devices that were implanted in patients in the U.S. and those who received them may have been subjected to severe pain or placed at risk of complications. In many cases, device failure will result in a requirement for knee revision surgery.
What Zimmer Persona Lawsuits Are There?
The Zimmer Persona Knee recall affected nearly 12,000 components that may have been implanted in patients who were placed at risk of early device failure. Many people have filed lawsuits to seek compensation for injuries caused by their Zimmer Persona knee device.
Zimmer-Biomet is not new to recalls or lawsuits. Over the past several years, the combined company has faced multiple recalls and thousands of lawsuits for harm caused by Zimmer and Biomet devices such as the Durom Cup, a hip device, and its NexGen knee devices. Some Zimmer-Biomet lawsuits have been settled but many may remain in various courts.
Several of these lawsuits have been successful. Zimmer Biomet has paid out $56 million in lawsuit settlements just in 2012 alone. Zimmer settled the remaining active lawsuits regarding its knee replacement devices in 2018.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.