Medical Malpractice Law
Zimmer Knee Replacements
Located in Memphis, TN
On March 12, 2015, the FDA announced a Class 2 knee implant recall for certain Persona knee implants made by Zimmer Orthopedics in Warsaw, Indiana. According to the FDA, the recall affects all lots and sizes of Zimmer’s Persona Trabecular Metal tibial plates.
The FDA’s knee implant recall said that the recall was prompted “following an increase in complaints of radiolucent lines and loosening.” Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on February 16, 2015. In Australia, the Therapeutic Goods Administration posted a “Hazard Alert” for the Persona Trabecular Metal tibial plates, saying that “it has been identified that there is a higher than expected rate of complaints for loosening of these devices.”
Zimmer distributed more than 11,000 of the subject knee implants before the recall. According to the FDA’s knee implant recall, Zimmer sold the implants throughout the United States, including in California, Florida, Ohio, New York, Pennsylvania, and Texas. Zimmer also sold the implant to Veterans Administration Hospitals, including those in San Diego, St. Louis, and Buffalo.
Zimmer started selling the Persona knee implant in the United States in 2012. But prior to Zimmer selling Persona knee implant, Zimmer never completed clinical trials and it did not obtain Premarket Approval from the FDA.
Shortly after Zimmer began selling the Persona knee implant in 2012, it started receiving reports of adverse events associated with the knee implant. For example, in January 2013, Zimmer received a report from a surgeon that a patient’s Persona knee implant had loosened and that “radiolucent lines” had developed. Zimmer continued to sell the Persona knee implant for three more years until it was finally recalled because of the exact same complaints.
In April and May 2013, doctors reported more cases of patients having to undergo a revision surgery because of radiolucent lines and loosening. Yet, Zimmer continued to sell the implant for almost another two years after this reported event.
To date, the FDA has received more than 200 reports of adverse events related to the Zimmer Persona knee implant. Most of these events are classified as either injuries or malfunctions. Please call the Chiozza Law Firm for a list of adverse reactions and to discuss your case in detail. This is a free, no obligation consultation.
If you have been injured by the Zimmer Persona knee implant, you may be entitled to compensation. Please contact The Chiozza Law Firm via this site or give us a call at 901-526-9494.