The U.S. Food and Drug administration has announced a recall of more than 11,600 Zimmer Persona Trabecular Metal Tibial Plate knee replacement devices. The recall, issued March 12, 2015, is a Class II recall and the FDA has warned that the implants may loosen and result in early device failure and complications.
The manufacturer has stated that the recall is “voluntary” but it was issued by the FDA after the agency had received too many reports of “radiolucent lines” which indicate large gaps developing between the implanted device and healthy bone. These gaps indicate that the joint replacement has loosened and is no longer securely attached. It may result in a number of complications, some of which may be severe.
Zimmer Knee Replacement Products
Zimmer has been manufacturing knee replacement devices for decades including both total and partial knee joint replacement products and some devices designed just for women. The Zimmer NexGen system is one of the implant manufacturer’s main product line but is facing thousands of lawsuits after causing serious injuries.
Like the NexGen, the Zimmer Persona knee replacement devices were designed to be more natural for an active population and to be longer lasting for a younger demographic. Unfortunately, many Zimmer Persona devices are showing signs of early failure.
The FDA issued a Class II recall for the Persona knee replacement devices indicating that there was potential for harm. Knee replacement devices such as the Zimmer Persona that show early failure rates may cause severe side effects and serious adverse events, sometimes resulting in a need for knee revision surgery.
Zimmer Persona Approval and Recall
Many of the knee replacement products on the market today, including the Zimmer Persona knee device, were approved under a “fast-track” procedure. The 510(k) Pre-market Authorization process allows manufacturers to avoid costly clinical research in human patients.
Under the 510(k) program, the manufacturer can claim that the new device is similar to products already on the market. Because of this approval process, some lawmakers have called for greater supervision by the FDA but no changes have been made and devices such as the Persona continue to be approved without adequate testing in humans.
The FDA has received numerous reports regarding the Persona and the occurrence of “radiolucent lines” which means that x-ray imaging shows large gaps developing between the implant and healthy bone surfaces. This generally indicates that the joint devices have loosened and are no longer stable.
The FDA has sent urgent warnings to physicians, hospitals and surgical centers requiring that implantation of the devices be discontinued immediately and all stock quarantined, but many patients have already had the Persona implanted. These patients, believed to number over 11,500, may be potentially facing early failure and serious side effects.
Side Effects of Zimmer Persona Failure
In most cases, side effects of knee replacement devices such as the Persona are mild to moderate and may go away with time. These side effects may include bruising and swelling of the knee along with stiffness and moderate pain.
In other cases, complications may be more serious and ultimately lead to knee revision surgery.
Complications may include:
- Severe or increasing knee pain
- Blood vessel and nerve damage which may be permanent
- Particle shedding from device that may cause damage to surrounding tissue
- Fractures in bone surrounding implant
- Device failure resulting in dislocation
Specifically, the Zimmer Persona Trabecular Metal Tibial Plate knee replacement device has shown an increased chance of radiolucent lines which indicate that dislocation may be occurring. These patients and any patients with other severe adverse events may be required to undergo knee revision surgery.
Knee revision surgeries are often more invasive and more complicated than the original surgery. The faulty joint must be removed and replaced with a different device. The revision and any required reconstructive surgeries may be more painful and require a significantly longer recovery period.
Zimmer Persona Lawsuits
Zimmer has faced thousands of lawsuits for harm caused by previous devices including the Durom Cup, a hip device and the NexGen knee devices. Some of the cases have been settled but many still remain in local, state and federal courts. Zimmer is currently facing one recall of the Persona line, but in other recall cases, additional members of the product line have been added, consequently the current recall may be expanded in the future.
Patients who have received the Zimmer Persona knee implant should be aware that the product has been recalled and they may be facing knee implant failure. In some cases of recall, representatives of the manufacturer will contact affected patients and offer an early “settlement” in exchange for a waiving of rights.
A patient or family affected by a device recall, or who has been injured by a medical device such as the Zimmer Persona should contact an attorney before giving any statement to the manufacturer, insurance company or representatives.
Revision surgery is a serious medical procedure that poses additional risks and patients who are required to undergo this procedure may be eligible for compensation for medical costs, lost wages and other damages caused by a faulty medical device.
Zimmer Holdings, Inc. is an Indiana-based manufacturer of orthopedic and joint replacement devices. It is the largest manufacturer of knee replacement devices with nearly 30 percent of the knee implant market.
Zimmer has an estimated annual revenue of $4.6 billion with over one-third of that income based on knee implants manufactured by the company. With the impending acquisition of Biomet, another orthopedics company, Zimmer will be the second largest manufacturer of all orthopedics devices around the world. Biomet has estimated annual income of $3.4 billion and after the $13.4 billion acquisition, the total revenue of Zimmer is expected to be around $8 billion annually.
Zimmer has manufactured hundreds of different orthopedic devices but over the last several years, the company difficulties with several of its knee and hip replacement products. The new Zimmer Persona Knee recall is only the most recent of several that have been issued for Zimmer knee devices. Other devices that have shown similar failures have resulted in serious complications and thousands of lawsuits.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.