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Zimmer Persona Knee Lawsuit

In yet another serious setback for beleaguered medical device maker Zimmer, Inc., its recently-introduced Personal Trabecular Metal Tibial Plate knee system is now the subject of a voluntary recall which has been followed by the issuance of a Class II recall by the FDA.

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Among recalled products are a series of sizes and lot numbers of Persona plates utilized during knee replacement surgeries performed during the period of late 2012 through early 2015. As a result of these developments, it is expected that numerous plaintiffs will soon decide to initiate a Zimmer Persona knee lawsuit to obtain compensation for their injuries and to help hold the manufacturer accountable for its alleged negligence.

Brief History of Zimmer Persona Knee Components

Brought to the U.S. market a mere three years ago, Zimmer touted its Persona knee components as a true innovation in the field, able to provide an unsurpassed fit to an individual patient’s distinct anatomy and biomechanical requirements. As it turns out, however, reports of serious problems with the devices began to emerge to in such volume as to prompt the device manufacturer to voluntarily recall more than 11,000 units of its Persona Trabecular Metal Tibial Plate system. The FDA quickly followed up with its own Class II recall dated March 12 of 2015. A Class II recall is issued by the FDA if and when a product is found to potentially produce temporary or reversible health effects that are adverse in nature, but the issues associated with the product have the ability to cause serious complications.

High Rate of Failure Seen in Zimmer Persona Devices

Zimmer issued an Urgent Medical Device Recall notice to physicians stating that of all complaints that had been submitted related to the components, 36 percent of patients reported complications relating to radiolucent lines, with substantial other numbers of patients requiring revision procedures due to joint loosening. Radiolucent lines are visible gaps between joint replacement components or between artificial components and existing bone. The presence of these lines can be indicative of the need for painful, costly revision surgery, the prospect of which no joint replacement patient will ever relish. Nearly 28 percent of the cases examined were characterized by asymptomatic radiolucencies and many more had inconclusive yet still worrisome results. Zimmer itself has stated that six of every thousand of these implants had the possibility of failure, though that estimate is seen as unrealistically low by medical experts who have considered these findings.

Zimmer Persona Knee Litigation Expected to Take Root

Those who have experienced serious pain and suffering as a result of their defective Zimmer Persona knee components are expected to begin filing lawsuits as a means to secure financial compensation as well as a degree of accountability on the part of the device manufacturer. Such lawsuits are likely to allege that Zimmer did not perform an adequate amount of research and testing prior to aggressively bringing these implants to market, ultimately causing them harm. Typical complications and injuries likely to be alleged by Zimmer Persona plaintiffs include:

  • Excessive fluid build-up
  • Tissue debris accumulations
  • Bone damage known as osteolysis
  • Severe pain
  • Excessive amounts of swelling
  • Losses or reductions in mobility

Because litigation pertaining to Zimmer Persona knee components is in still its infancy, it is difficult to predict just how voluminous lawsuits of this nature will eventually grow to be. However, given the frequency with which our aging population undergoes total knee replacement procedures, it seems reasonable to assume that these cases will pose yet another major obstacle to Zimmer’s recovery from past legal troubles including large-scale lawsuits over its Durom Cup hip devices and NexGen knee components.

 

Sources:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=133978

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=86898

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm

 

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