Affected by the zimmer knee recall?
Affected Devices: Zimmer Persona Trabecular Metal Tibial Plates that were implanted without cement. The Metal Tibial Plate is one of the component parts in the Zimmer Persona Knee Implant System. Zimmer admitted the worldwide recall affected 11,568 devices.
- Relevant Dates: November 29, 2012, to January 23, 2015.
- Contact our Lawyers in Tuscaloosa, AL if you’ve been impacted.
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Reasons for Recall
Reason for Recall: According to Zimmer, the Persona Trabecular Metal Tibial Plate has higher than expected rates of complaints of radiolucent lines and loosening. Loosening of the tibial plate can result in severe pain and the need for revision surgery.
Device Explained: A total knee replacement usually consists of four component parts (shown above): the femoral component, tibial baseplate, tibial insert (plastic), and patella. The only component part that Zimmer recalled is the metal tibial plate (shown below) which can become loose requiring revision surgery. Zimmer claimed the Trabecular Metal Technology eliminated complexity, procedure time, and third-body wear by removing cement from the surgical procedure.
Device Explained: A total knee replacement usually consists of four component parts (shown above): the femoral component, tibial baseplate, tibial insert (plastic), and patella. The only component part that Zimmer recalled is the metal tibial plate (shown below) which can become loose requiring revision surgery. Zimmer claimed the Trabecular Metal Technology eliminated complexity, procedure time, and third-body wear by removing cement from the surgical procedure.
Patient Compaints
There have been 40 complaints worldwide of the device loosening, as of March 16, 2015. At least 16 of these complaints have required revision surgeries.
Reported Side Effects & Complications
- Loosening of the implant
- The appearance of radiolucent lines
- Severe Pain
- Difficulty Walking or Bending the knee
- Inflammation
- Knee Instability
- Knee Tightness
- Numbness or stiffness in the leg
- Revision surgery or recommendation for revision surgery
Device Locations
According to Zimmer, the recall affects 11,658 of these knee components worldwide. Zimmer distributed the recalled Persona Trabecular Metal Tibial plates in at least 25 states and at 13 major Veterans Administration centers.
Types of Loosening
There are two types of loosening: aseptic and septic. Septic loosening is loosening to due infection which is proven by positive cultures or a sinus tract communicating with the joint at revision. Aseptic loosening is loosening caused by micromotion, bone stock deficiencies, inadequate porous coating design or contaminants.
Timeline of Events
- March 27, 2012 FDA approved the Zimmer Persona Personalized Knee System (for cemented use only). Zimmer marketed the Persona Knee as the “most clinically successful knee replacement more personalized than ever
- November 7, 2012 FDA approved the Zimmer Persona Trabecular Metal Tibial Baseplate for cemented OR uncemented use.
- February 16, 2015 Zimmer issued an “Urgent Medical Device Recall Notice” to distributors, hospitals and surgeons regarding the uncemented Zimmer Persona Trabecular Metal Tibial Baseplates. Zimmer asked customers to review the notification and ensure personnel are aware of the contents. Zimmer additionally requested that all affected products be located and quarantined immediately.
- March 3, 2015 Zimmer issued an “Urgent Medical Device Recall Notice” to hospital risk managers and surgeons. Zimmer said that the current complaint rate for radiolucent lines and loosening is higher than Zimmer’s expectations and experience based on Zimmer’s similar devices. At this time, the complaint rate was 0.61% or 6 complaints per 1,000 devices. Out of the complaints received, 36% identified symptomatic radiolucent lines or were revised for loosening, 28% identified asymptotic radiolucencies, 8% subsided, and 28% were inconclusive.
- March 12, 2015 Zimmer voluntarily recalled the Persona Trabecular Metal Tibial plate that is porous coated and uncemented. The recall affected all lots and sizes C-J Left and Right. The Food and Drug Administration categorized this as a Class 2 Recall which is defined as “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
- March 20, 2015 Therapeutic Goods Administration (the Australian equivalent of the FDA) announced a Hazard Alert regarding Zimmer’s Trabecular Metal Tibial Plate. March 31, 2015 Surgeons began sending letters to affected patients notifying them that they received one of the recalled, uncemented Metal Tibial Baseplates.
- March 31, 2015 Surgeons began sending letters to affected patients notifying them that they received one of the recalled, uncemented Metal Tibial Baseplates. The letters instruct patients to come in for a free initial evaluation where the consultation fee and imaging studies will not billed to their insurance. This letter also steers patients to Zimmer.
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