In January 2015, the Zimmer Co. initiated a recall of its Persona Trabecular Metal Tibial Plate—a component of a total prosthetic unit used in knee replacements. The Persona Trabecular Tibial Plate sits on top of the main lower leg bone, providing a surface for the rest of the artificial joint to act upon.
The Personal Trabecular Metal Tibial Plate is implanted into the tibia—one of two bones of the calf region—with the use of bilateral pegs. The pegs are expected to adhere to the bone of their own accord by growing into the tissue, rather than through the use of surgical cement.
In the U.S., the manufacturer’s recall of the Persona Trabecular Metal Tibial Plate affected over 12,000 of these Total Knee Arthroscopy (TKA) prosthetic parts. The recall was started because of a growing body of complaints from recipients of the component. The symptoms that were a part of these complaints were indicative of possibly prosthetic failure.
A good number of patients had already had their Persona Trabecular Metal Tibial Plate removed—along with the rest of the knee replacement unit—in knee revision surgeries. For those that had not, diagnostic imagery undertaken to determine the cause of the pain, swelling, and dysfunction of the joint often revealed radiolucent lines.
Radiolucent lines are gaps between the tibia and the Persona Trabecular Metal Tibial Plate which demonstrated to the trained medical eye that the part had migrated from its originally-placed position. This movement could be an early indicator of a later failure.
The U.S. Food and Drug Administration (FDA) assisted the Zimmer Co. by formalizing this action and handling notification of the general public and medical professional community. The recall of the Persona Trabecular Metal Tibial Plate was classified as Class 2 recall—reserved for assistive mechanisms that can only cause temporary or reversible harm.
Removal of a total knee prosthetic can cause the loss of bone tissue and subject the patient to life-threatening surgical risks such as blood clots. The loss of bone tissue can make the adherence of a new unit difficult for some patients and lead to life-long problems such as leg length discrepancies. Traveling blood clots, common with such invasive surgeries as knee and hip replacements, can cause tissue death, respiratory and cardiac arrest, and stroke—several of which are not ‘reversible’ in the damage they cause to the person involved.
Were you implanted with a Zimmer Persona Trabecular Metal Tibial Plate or other prosthetic unit that has seemingly been the source of ongoing pain, swelling or limited range of motion and mobility? Many joint replacement recipients are unaware of the type of prosthetic used by their orthopedic surgical team.
Investigation of your situation with the assistance of an expert product liability lawyer may help you recover funds to pay medical bills and replace lost wages.
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If you or a loved one suffered from complications caused by an Attune knee implant, an Arthrex knee implant, or an Exactech knee implant, you may have a legal claim. In general, knee replacement surgery lawsuits are filed individually by each plaintiff and are not class actions. Get help now by filling out the form on this page for a FREE case evaluation.
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