In March 2015, the U.S. Food and Drug Administration (FDA) announced a Zimmer Persona knee implant recall affecting the implant system’s trabecular metal tibial plate. The tibial plate is the part of the implant system that attaches to the top of the lower leg bone, using two pegs designed to grown into the surrounding bone tissues.
Signs of Complications
After the knee implants were made available and on the market, reports said these tibial plates had been subject to premature loosening and radiolucent lines, both signs of improper implant function. In some reported cases, the two tibial pegs failed to grow into the surrounding bone.
Patients who received the Zimmer Persona knee implant may be in for significant and painful complications that may require revision surgery. Radiolucent lines are evidence found in X-rays of a gap between the tibial plate and the adjacent bone. This gap can form when the plate moves away from its proper position due to poor seating.
The manufacturer, Zimmer, initiated the recall voluntarily in late January 2015, according to the FDA. The Zimmer Persona knee implant recall impacted close to 12,000 individual units from all lots and sizes that were distributed between 2012 through the beginning of 2015. All units affected by the recall were to be removed from distribution.
The FDA designated this Zimmer Persona knee implant recall as a Class II recall, which applies to situations where a product “may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.”
Product liability attorneys at Parker Waichman are actively reviewing potential lawsuits regarding allegedly defective medical devices including Zimmer Knee implants.
Zimmer Seeks to Improve Knee Implant
Problems like those reported with the Zimmer Persona components may cause the implant to fail to remain properly implanted. Failure of ingrowth may cause components to come unattached, possibly leading to mechanical failure of the implant.
These complications may case a patient to experience instability, fractures, chronic pain, patella tracking problems, and discomfort or tightness in the knee. According to Zimmer, loosening of implant components is one of the most common causes of the need for revision surgery among knee arthroplasty (replacement) patients.
Issues with Revision Surgery
Revision surgery brings its own set of complications. It is typically more involved than an original knee implant surgery. For that reason, it can put the patient at a greater risk for complications and may require a significantly longer recovery time.
Revision surgery patients are more likely to experience pain, infection, blood clots, or fractures. They may also be at a greater risk for loss of bone or damage to surrounding nerve or muscle tissue, and they may end up with a leg length discrepancy.
Complications from a defective knee implant can be extremely burdensome on the patient. These complications that may arise from the procedures may far exceed what the patient was led to expect from the product information provided by the implant’s manufacturer, in this case, Zimmer.
Potential Serious Infections with Knee Replacement
A knee replacement patient contracted a MRSA infection after her knee replacement and had subsequently to undergo several corrective surgeries. The patients has been disabled since that knee replacement ten years ago.
MRSA is methicillin resistant Staphylococcus aureus, a bacterial “staph” infection, that is resistant to many of the standard antibiotics.
Hundreds of hip and knee replacement patients have filed lawsuits against various manufacturers, often due to the length of time in surgery. The patients claim that some equipment may stir up contaminated air from the operating room floor that gets into the surgical site, causing deep joint infections, requiring additional surgeries, amputation, among other complications.
Another case was cited, where a patient had to have four knee surgeries due to a deep bone marrow infection. After some investigation, the patient came across the Bair Hugger blanket as a possible contributor to the problem. He said, “How else could I have gotten a deep bone marrow infection that I didn’t have before going into that operating room.”
Have You Been Injured by a Zimmer Knee Replacement Implant?
If you or someone you know has sustained injury associated with a knee replacement implant, you may be eligible for valuable compensation. Parker Waichman personal injury law firm has handled many cases involving a broad spectrum of devices, including Zimmer knee replacement implants. The firm offers free, no-compensation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).