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
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.
Patient Complaints: 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.
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.
Loosening of the implant
Appearance of radiolucent lines
Difficulty Walking or Bending knee
Numbness or stiffness in the leg
Revision surgery or recommendation for revision surgery
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.
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. 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.
A: The operative report and knee implant labels, often called Chart-Stick® labels, from the hospital will identify the specific devices that were implanted.
A: Always consult your doctor or surgeon regarding health-related issues, but if you or someone you care about received a recalled knee replacement, we would like to speak with you right away. DO NOT SIGN A RELEASE FROM THE SURGEON OR ZIMMER. This release will allow Zimmer complete access to your medical records and also allow them to obtain the failed implant in the event it is removed.
A: If you have pain and/or swelling in or around your knee replacement, you should schedule an office visit with your orthopedic surgeon to discuss your symptoms and to have radiographs (such as X-ray/Bone Scan/MRI) performed to see if there are signs of radiolucent lines or loosening. Additionally, consider keeping a journal of your symptoms. We have found this to be extremely helpful in representing clients and it assists us in personalizing your claims when we present them for settlement or trial.
A: Even if you do not have symptoms at this time, you should at least visit your orthopedic surgeon for an evaluation and have radiographs performed. You should continue the post-operative plan outlined by your surgeon. Pay close attention to any pain or problems that you believe are being caused by your knee implant.
A: If you are experiencing any of the symptoms described above, you need to see an orthopedic surgeon to be evaluated. The only way to confirm loosening is by radiographs such as X-ray/Bone Scan/MRI. Pain and swelling are symptoms of loosening.
A: Potentially. If there is any evidence of implant loosening or radiolucent lines around the tibial portion of the knee replacement, your surgeon might recommend a revision surgery to remove and replace the uncemented tibial plate. This is a difficult decision that you must make based on your surgeon's recommendation. The only way to resolve a loose tibial plate is to remove and replace this component part.
A: It is important to speak with a lawyer immediately as your statute of limitations has begun to run. Additionally, it is important that the device that was removed and replaced is located and preserved.
A: No. You should contact a lawyer before communicating with Zimmer and avoid signing a release. We do not recommend providing Zimmer with a release or providing them with any of your medical records.
A: We only sue the implant manufacturer for designing, manufacturing, and marketing a defective product. We do not sue the implanting surgeon or hospital.
A: According to Zimmer, this component part had higher than expected rates of complaints of radiolucent lines and loosening.
A: Some common complications are trouble walking, standing or bending, pain or swelling in the knee, a loose feeling in the knee, or a need for a revision surgery.
A: On March 12, 2015, the F.D.A. announced that the tibial plate was voluntarily recalled by Zimmer. The recall was due to the growing number of complaints of radiolucent lines and loosening. It is believed Zimmer knew about these problems before the first recall notice in February 2015.
A: It is estimated that Zimmer sold 11,568 recalled knees worldwide. The exact number implanted is unknown. It is estimated that at least 6,500 were sold in the USA.
A: Zimmer distributed the recalled Persona Trabecular Metal Tibial plates in at least 25 states:
AL, AR, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, MY, OH, OK, PA, TN, TX, UT,
VA, WA, & WI. Zimmer distributed the recalled Persona Trabecular Metal Tibial plates at 13 major Veterans' Administration centers: Birmingham, AL; San Diego, CA; Augusta, GA; Indianapolis, IN; Maine; West Roxbury, MA; St. Louis, MO; Reno, NV; Buffalo, NY; Sioux Falls, SD; Dayton, OH; and Lebanon and Wilkes Barre, PA.