The FDA announced in March 2015 that Zimmer Biomet had issued a voluntary recall of the Zimmer Persona Trabecular Metal Tibial Plate, a knee implant component, due to injury reports of the device loosening from its initial implant position.
The company voluntarily recalled 12,000 knee replacement systems containing the Zimmer Persona TM Tibial Plate. The FDA Zimmer knee recall announcement detailed major injury complaints alleged by patients, including:
- Radiolucent Lines: X-rays showed gaps between the knee implant component and the bone, which indicates “poor seating.” Poor seating occurs when the implant moves from the initial implant site. Radiolucent lines are early signs of device loosening.
- Device Loosening: Injury reports state that the trabecular metal plate was coming loose from its initial position. Zimmer states that device loosening “is one of the most prevalent causes for revision in total knee arthroplasty.”
The FDA designated the Zimmer recall as a Class 2 recall. A Class 2 FDA recall is designated for drugs and medical products that cause treatable or temporary injuries to patients.
According to the federal agency, all sizes and lots of the Zimmer Persona Trabecular Metal Tibial Plate are affected.
In addition, the Zimmer Personal Tibial Articular Surface Provisional (TASP) Shim tool was also recalled due to one of the device’s components reportedly breaking during surgical procedures.
Overview of Zimmer Knee Implant Complications
The Zimmer Persona Trabecular Metal Tibial plate is part of a medical device designed to be implanted for total knee replacement into the bone without cement binding the device to the bone.
The Zimmer Trabecular Metal Tibial plate is directly attached to the tibia, with two pegs inserted into the bone that are supposed to “grow” into the bone to provide stability. Zimmer stated that many of the injury reports indicated that 38% of patients who had the Persona Trabecular Metal plates had experienced device loosening and had to undergo revision surgery.
Even though revision surgery resolved the initial problems with the knee implants, this procedure is considered more high risk than the initial implant procedure. Symptoms of failing Zimmer Persona knee implants reported by patients include:
- Debilitating Pain
- Loss of Mobility
- Inflammation
- Knee Instability and Tightness
- Device Loosening
- Fracture
Patients who opted for the Zimmer Persona knee implant and later had to undergo revision surgery may be able to file legal action against the manufacturer. Potential claimants may be able to file a Zimmer Persona knee implant lawsuit, and should contact a medical device lawyer to determine eligibility.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The hip 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, metal hip implant lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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