On March 12, the U.S. Food and Drug Administration 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” and loosening of the devices.
The recall affects 11,638 devices that have been implanted in the U.S. and patients who have received them may be at risk of complications and may be required to undergo knee revision surgery.
Zimmer Persona Approval
Zimmer Persona 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.
The Persona knee implant was approved 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.
The 510(k) process is quicker than a traditional approval route and some opponents have called for its discontinuation but the process has not been changed. Consequently, the Zimmer Persona had not been testing in human subjects before it was released for public use.
Since its approval in 2012, the FDA has received multiple 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, 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 have 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.
Currently only the Zimmer Persona Trabecular Metal Tibial Plate is affected by the recall, but in some other cases, recalls for additional components have been required after the initial event, particularly when the devices are comprised of multiple components as the Persona is.
Zimmer Persona Side Effects
Most knee replacement devices of any type carry a number of side effects. Bruising, swelling, pain and stiffness generally go away after a period of time.
Other side effects caused by a failing knee joint replacement device 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
The current complaints and recall are based on loosening of the joint – or device failure. This may cause the joint to become unstable and result in immobility. It can also cause injury or damage to surrounding tissue.
Unfortunately, though a recall has been issued, some patients may not yet know that they are facing early device failure. If the malfunctioning device is not replaced, it may cause additional injury. In addition, some injuries may have already occurred.
Zimmer Persona Lawsuits
Even if additional complications do not occur because of the development of radiolucent lines or joint loosening, revision surgery to remove and replace the device is often more invasive and painful than the original procedure. No matter what the reason, revision and reconstructive surgeries pose significant surgical risk and may take a much longer recovery time.
Zimmer is not new to recalls or lawsuits. Over the past several years, the company has faced multiple recalls and thousands of lawsuits for harm caused by Zimmer devices such as the Durom Cup, a hip device and its NexGen knee devices. Some Zimmer lawsuits have been settled but many may remain in various courts.
The Zimmer Persona knee recall does not absolve the Zimmer Company of responsibility to the patient. Patients who must undergo revision surgery to replace a failing device or those who have been injured by a faulty device may be eligible to receive financial reimbursement and compensation medical costs, lost wages and other types of damages, including pain and suffering.
Some manufacturers will attempt to contact affected patients directly to discuss their medical case and to offer a small settlement. In exchange, patients are often required to sign documents that “waive” their rights and prevent them from getting any additional help in the future.
Patients who have received the Zimmer Persona knee implant should be made aware of the recall and the potential for early failure but should consult an attorney before discussing any medical information or agreeing to any settlement.
Zimmer Holdings, Inc. is the largest manufacturer of knee replacement devices in the world with an estimated revenue of $4.6 billion annually. The Indiana-based company has just received European approval for a $13.4 billion acquisition of Biomet, another orthopedics device company who has an estimated annual revenue of $3.4 billion. After the merger, Zimmer will be the second largest orthopedics manufacturing company in the world.
Zimmer has a long history of manufacturing joint replacement devices and other orthopedics products. Most of the Zimmer products have functioned well, but others have not. In recent years, Zimmer has faced thousands of lawsuits regarding several products including the Durom cup hip implant and the NexGen knee implant, many of which have not yet been settled.
The most recent recall of the Zimmer Persona knee implant may also result in lawsuit filings as patients become aware of the complications caused by the faulty devices.