Zimmer Persona Knee Recall
Like its predecessor, NexGen, the Zimmer Persona Knee system was designed for a younger and more active demographic and intended to closely mimic the natural action of the knee. Just three years after its 2012 approval however, a major component required the FDA and manufacturer to issue a 2015 Zimmer Persona Knee recall for the Trabecular Metal Tibial plate used as part of the system.
The recall was issued after multiple reports had indicated patients were experiencing severe pain, device loosening and subject to knee revision surgery at a higher than expected rate.
Zimmer Persona Knee Complications
Zimmer Persona Trabecular Metal Tibial plate has shown to be subject to loosening which may result in serious pain, joint instability and device failure. Reported complications include:
- Severe knee pain
- Blood vessel and nerve damage
- Damage to joint tissue
- Bone fracture
- Joint dislocation
Patients who suffer device failure are often required to undergo one or more revision surgeries to remove and replace the faulty device.
Zimmer Persona Knee Recall
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.
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.
The recall affected 11,638 devices that were implanted in patients 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.
Zimmer Persona Approval
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 in 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 testing in human subjects before it was released for public use.
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.
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 a revision surgery is performed to remove and replace the faulty device. If device failure is not caught early enough, serious complications may result.
Zimmer Persona Side Effects
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 which 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 device
- Bone fracture in area surrounding 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.
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.
Zimmer Persona Lawsuits
The Zimmer Persona Knee recall affected nearly 12,000 components which 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.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.