Zimmer Sued over Persona Tibial Plate Knee Implant
A new lawsuit has been filed over the Zimmer Persona Tibial plate, which was recalled in 2015 due to loosening and radiolucent lines. The plaintiff alleges that the knee implant device is defective, resulting in injuries. He is seeking damages for economic loss, and pain and suffering.
Parker Waichman LLP is a national law firm with decades of experience representing clients in medical device injury litigation. The firm is offering free legal consultations to individuals interested in filing a Zimmer knee implant lawsuit.
According to court documents, the plaintiff is a New Hampshire man who underwent total knee replacement with the Zimmer Persona tibial plate in August 2014. He alleges that the plate failed, prompting him to undergo revision surgery in April 2015.
The lawsuit states that the plaintiff “suffered injuries as a result of implantation and revision/explantation of the Zimmer Persona Knee device manufactured by defendants.”
He also alleges that the Zimmer Persona tibial plate defects caused “economic loss, diminished earning capacity, [and] pain and suffering, from the permanent injuries caused by the defective knee device.”
The suit also claims that the plaintiff’s knee is in worse condition after the revision surgery, stating “the revised knee implant is not functioning at its full potential, due to the loss of bone cartilage, surface and tissue from the original defective knee device,”
The lawsuit alleges that neither plaintiff nor his physician could have known that the knee implant was defective when it was implanted.
Zimmer Persona Knee Implant Recall
In 2015, Zimmer recalled the Persona Trabecular Metal Tibial Plate due to loosening and radiolucent lines.
Zimmer pulled the product due to “An increase in complaints of loosening and radiolucent lines,” according to a U.S. Food and Drug Administration (FDA) safety alert. The recall affects about 12,000 knee implants.
The presence of radiolucent lines means that there is space between the bone and knee implant, which indicates that the device is moving from its intended fixed location. Knee implant patients also reported loosening, which impacts the trabecular metal plate.
Persona knee implant loosening may cause complications and adverse events that ultimately prompt an early revision surgery, where the failed device is removed and replaced.
Patients with the recalled Zimmer Persona knee implant may experience symptoms and complications including:
- Loosening at the implant site
- Patella tracking problems
- Tightness in the knee
- Device failure
- Revision surgery
The FDA classified the recall as Class II, indicating that exposure to the recalled device can lead to temporary or medically reversible injuries. They can also indicate situations where the risk of serious injury is rare.
The Uncemented Persona Personalized Knee System was approved in 2012 via 510(k), a fast-track approval route where device makers do not need to submit clinical data for safety or efficacy prior to obtaining approval. Products cleared through 510(k) only need to be “substantially equivalent” to a previously approved device on the market. This expedited process was not intended for high-risk devices, but some high-risk products were approved through 510(k) due to a regulatory loophole.
510(k) has come under criticism because it was used to approve certain controversial medical devices, including transvaginal mesh and metal-on-metal hip implants.
Other Zimmer Joint Replacement Recalls
Other recalls have been issued for Zimmer joint replacement products. The Zimmer Comprehensive Reverse Shoulder System was recalled recently because the device was fracturing at higher rates than reported on the labeling.
“Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling,” the recall alert states. “Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”
Regulators gave its most serious Class I label, meaning that exposure to a recalled device can lead to serious injuries or death.
Zimmer also recalled a hip implant product in 2015. The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology was recalled due to “higher than allowed cytotoxicity levels found with the product. Reasonable probability of adverse biological response and subsequent revision.” The FDA labeled the recall as Class I.
Filing a Zimmer Joint Replacement Lawsuit
Parker Waichman has years of experience representing clients in medical device injury lawsuits. If you or someone you know is interested in filing a Zimmer joint replacement lawsuit, contact one of our experienced product liability lawyers today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).