By Tracy Colman  |  May 31, 2018

Category: Legal News

Zimmer Persona Tibial Plate Recalled Due to Reports of MalfunctionThe Zimmer Persona tibial plate is a part of the Zimmer Persona Knee Implant prosthetic. The tibial plate is called such because it attaches to the top of the major lower leg bone known as the tibia. The Trabecular Metal (TM) Persona tibial plate has two feet known as pegs which are implanted into this bone without the use of surgical cement.

The original idea behind this innovation was that the body would allow the pegs to eventually grow into the bone tissue and stabilize the surface. This surface is where the rest of the prosthetic articulates and moves.

In March of 2015, the Zimmer company voluntarily recalled the TM Persona tibial plate of the prosthetic knee implant used in total knee arthroplasties (TKAs). TKAs are done to assist patients that have developed or otherwise sustained hereditary, age or trauma-related arthritis or other knee joint damage.

After implantation of the TM Persona tibial plate, several former patients had reported numerous symptoms indicative of prosthetic failure. Upon close review of diagnostic X-ray images, spaces between the plate and the bone were showing up.

These spaces or gaps–called radiolucent lines–revealed that the Persona tibial plate could be moving from its original placed position and undergoing overall loosening.

The Zimmer company initiated the recall process in January 2015, and the U.S. Food and Drug Administration formalized it with appropriate notification and categorization as a Class 2 recall. Class 2 recalls are for medications and medical devices that are capable of only causing temporary or reversible harm to the patient. The recall involved a total of 12,000 domestically-distributed TM Persona tibial plates.

The Zimmer company, based out of Warsaw, Ind., indicated that of those patients that had reported complaints about their Persona tibial plates, 38 percent had either visible radiolucent lines when evaluated or had already undergone knee revision surgery to remove the prosthetic component or whole unit due to failure.

A first knee replacement surgery is not without significant risk. A patient having to be subjected to a repeat performance is likely to have the risk factors ratcheted up a few notches.

Among the inherent dangers are bone tissue loss and difficulty getting a new prosthetic unit to adhere, leg length discrepancies leading to lifelong limping, the possibility of life-threatening blood clots in recovery, deep joint infections, nerve or blood vessel damage, or focal tissue death.

The High Cost of Knee Revision

In addition to the high physical risks a patient takes when they must have a prosthetic removed and replaced, the costs of such surgeries are prohibitively expensive and can saddle a patient with exorbitant medical and hospital bills that can burden them for the long haul.

The monetary setback can be recovered along with compensation for unnecessary pain and suffering if a patient files a product liability lawsuit.

If you had a Zimmer Persona tibial plate implanted in a TKA surgery in the three-year-period between 2012 and 2015, and have suffered any of the following symptoms or had the component or total prosthetic unit removed, you may have a legal claim:

  • Pain and Swelling
  • Fracture
  • Joint Tightness or Instability
  • Loss of Ability to Move the Joint

A consultation with a knowledgeable medical products attorney can help you understand your legal rights and options.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The knee implant attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, knee implant lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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