The Zimmer Persona tibial plate recall was initiated by Zimmer in February 2015, due to numerous reports of early device failure. The FDA issued its own recall announcement not long after giving the Zimmer Persona tibial plate recall a Class II designation, which is reserved for medical products shown to cause reversible or temporary harm to patients.
The Persona tibial plate recall encourages the medical community and patient population to be aware of these potential problems when evaluating whether or not the Zimmer Persona knee replacement system is the right choice for them.
Like other prostheses, the Zimmer Persona knee replacement system is often prescribed to patients who have sustained serious damage to the knee joints from either injury or degenerative disease.
The concern revolving around the Zimmer Persona knee replacement surgery stems from the trabecular metal tibial plate component, which allows the device to attach to the tibia without the use of cement.
Instead, the Zimmer Persona tibial utilizes two pegs that are directly inserted into the bone, to “grow” into the tibia and ultimately gives the prosthetic stability.
Overview of Zimmer Persona Tibial Plate Recall
However, the Zimmer Persona tibial plate recall has spurred major concern to the general public, especially for patients who have undergone knee replacement surgery with the prosthetic in the past.
The Zimmer Persona tibial plate recall affects nearly 12,000 trabecular metal tibial plates, with Zimmer warning that many patients have had to undergo revision surgery following the development of radiolucent lines.
Radiolucent lines are one of the primary complications associated with Zimmer Persona tibial plate failure, which can be seen in X-ray images. These lines or gaps appear between the knee prosthetic and the bone, and is an early sign of device loosening.
This leads into the other main complication associated with Zimmer Persona knee replacement problems. The trabecular metal plate can move out of its place from initial implantation position. Zimmer states that device loosening is “one of the most prevalent causes for revision in total knee arthroplasty.”
In addition to withdrawing potentially defective tibial plates, Urgent Medical Device recall notifications were issued to impacted distributors, hospitals, and surgeons. These notices asked medical care professionals to discuss these potential problems with patients, and to inform patients who already have the tibial plate in their knees.
In addition, the letters request healthcare facilities and distributors locate and quarantine all affected products and return them to the manufacturing company. While the Zimmer Persona tibial plate recall prevents future patients from being affected, patients who already had the prosthetic implanted should be wary against any signs of device failure.
According to injury reports, the complications patients reported experiencing include but are not limited to:
- Knee Swelling
- Tightness of the Knee Joint
- Debilitating Chronic Pain
- Fracture
- Knee Instability
- Limited Mobility
- Device Component Loosening
- Lack of Ingrowth
- Loss of Fixation
- Instability
- Patella Tracking Problems
- Inflammation
Patients who experience these problems may have to undergo revision surgery, which is considered riskier than the initial implant surgery. Patients who underwent implant surgery with the Zimmer Persona knee replacement system between 2012 to 2015 and suffered device loosening or radiolucent lines may be able to file a claim for compensation.
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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