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
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.