A Class II recall for the Zimmer Persona Trabecular Metal Tibial Plate knee implant was issued on March 12, 2015 by the Food and Drug Administration. The recall indicates that the device may loosen and cause the development of “radiolucent lines” or large gaps between the device and bone tissue.
The FDA has indicated that 11,638 implanted devices are affected and patients may require revision surgery. If identification of device failure is delayed, additional complications may result.
Zimmer Persona Approval and Recall
The Zimmer Persona knee device was designed to more closely mimic the natural action of the knee. It was designed for an active, younger demographic and was intended to be long lasting but has been recalled less than 3 years after its 2012 approval.
Like its predecessor, the NexGen knee replacement device and most other devices on the market, the Persona knee implant was approved using the FDA’s 510(k) shortcut process. The 510(k) process allows manufacturers to claim that a new device is “similar to and not substantially different from” other devices already on the market. Using the 510(k) process allows manufacturers to forgo costly clinical trials and the Zimmer Persona device was never tested in humans prior to sale.
The FDA has issued the Class II recall, indicating that the device may cause “temporary” or “reversible” harm. The recall was based on reports of radiolucent lines which indicate X-ray proof of joint loosening and the development of a large gap between the implant and bone structure. Loosened joints will usually have to be replaced through a revision surgery.
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 which, according to the FDA, has been implanted in 11,638 patients, is involved in the recall. Other components have not yet been listed, though in other multi-component systems, additional recalls were subsequently issued.
Zimmer Persona Lawsuits
Even though the Zimmer Persona recall was issued by the FDA as a Class II recall, indicating that medical harm may be reversible, Zimmer is not absolved of responsibility and may be facing hundreds of lawsuits by patients who have revision surgery or other complications.
This is only the latest in a string of device-related lawsuits that the Zimmer Company may be facing. The manufacturer has faced several recalls and thousands of lawsuits relating to harm caused by their other devices. Many of these lawsuits have yet to be settled.
In significant recall cases, some manufacturers or representatives may attempt to contact patients directly after the recall. They will attempt to gather medical information and may offer a settlement but in most cases, the patient must sign documents that release the manufacturer from further responsibility. This means that if additional complications occur, the patient will get no assistance and cannot file a lawsuit.
Patients who have received a Zimmer Persona knee implant should be made aware of the recall so that they can seek medical assistance. Patients who have experienced complications or who have been told they must have revision surgery should consult an attorney before discussing any of their medical information with a device manufacturer.
Zimmer Persona Side Effects
Bruising, swelling, mild-to moderate pain and a significant recovery time are normal side effects of joint replacement surgery but the devices may cause more serious adverse events including:
- Severe or worsening knee pain
- Blood vessel or nerve tissue damage
- Bone fractures and surrounding tissue damage caused by particles shed from device
Early implant failure may also cause joint loosening resulting in dislocation of the device. This is the basis of the current recall.
Radiolucent lines appear on an x-ray indicating that the device, which was previously cemented to bone has become loose and developed a large gap. Loosened and dislocated devices may cause instability and result in immobility and may cause additional injury.
Patients who have developed radiolucent lines, joint loosening or other severe side effects may be required to undergo revision surgery. Some patients also require reconstructive surgery and each subsequent surgical procedure poses additional risks and results in a significantly longer recovery time.
Zimmer Persona Revision Surgery
People who have received the Zimmer Persona knee implant device may be subject to device loosening or other complications. In many cases, these events will require revision surgery and some may require reconstruction as well.
Revision surgery involves removal of the faulty device and replacement with a new device. This additional surgery may be much more painful and debilitating than the first procedure, posing additional risks and requiring a much longer recovery time.
Patients who are required to undergo revision surgery or have suffered other complications due to the Zimmer Persona implant may be eligible for monetary awards to cover medical costs, lost wages, pain and suffering and other damages.
Zimmer Holdings, Inc. is the manufacturer of hundreds of joint replacement and orthopedics device products. It has an annual revenue estimated at $4.6 billion and will be the second largest orthopedics company in the world after it completes a planned acquisition of Biomet, another large orthopedics company. The post-merger annual revenue of Zimmer is expected to be about $8 billion annually.
Zimmer holds 26 percent of the knee replacement market and is the largest manufacturer of knee replacement devices in the world. While most of the Zimmer products have been successful, several have resulted in recalls and lawsuits including notable cases over the last several years involving the Durom cup hip device and the NexGen knee devices.