(Washington, D.C. – May 2, 2016) Zimmer Biomet is warning European surgeons about problems with the M2a 38mm metal on metal hip implants but has NOT issued any warnings in the United States for patients with the same hip implant.
On April 12th, Zimmer Biomet sent letters to surgeons in Europe admitting the M2a 38mm Acetabular System has a higher than expected revision rate. The warning also called a Field Safety Corrective Action (FSCA), is based on data collected by the National Joint Registry for England, Wales, and Northern Ireland. The letter calls on surgeons to follow patient care guidelines established back in 2012 by the Medicines & Healthcare Products Regulatory Agency (MHRA). The MHRA is the British version of the Federal Drug Administration (FDA) in the United States. The MHRA guidelines include annual patient exams, MARS MRI or ultrasound testing, blood metal ion level tests, and possible revision surgery. These follow-up guidelines are unique to metal on metal hip replacement patients because of health concerns.
“There are thousands of patients in the United States with the same medical complications and high revision rates due to the M2a 38mm hip implant. Don’t they deserve to know from the manufacturer if their health is at risk, too?” –Altom Maglio, Managing Partner, mctlaw
Zimmer Biomet has NOT yet issued ANY similar warnings in the United States aimed at doctors, consumers, or patients implanted with the M2a 38mm Acetabular System. Mctlaw discovered copies of the April 2016 Field Safety Notice (FSCA20160307) distributed in Italian, German, Danish, and English. However, the Field Safety Notice does not apply to the U.S. Last year, Zimmer Biomet stopped all supply and sales of the M2a in Australia and issued a Hazard Alert because data from the Australian Orthopaedic Association showed higher than expected revision rates. Again, Zimmer Biomet did not issue a Hazard Alert or other safety warnings in the U.S.
“Zimmer Biomet has not told any of our U.S. clients or their surgeons about the serious medical issues with the M2a,” says Altom Maglio, Managing Partner of mctlaw. “Why only issue a Field Action Warning in Europe and a Hazard Alert in Australia? There are thousands of patients in the United States with the same medical complications and high revision rates due to the M2a 38mm hip implant. Don’t they deserve to know from the manufacturer if their health is at risk, too?,” says Mr. Maglio.
The M2a 38mm implant was introduced in the global market in 2001. Soon after patients started reporting problems with these metal-on-metal hip replacements. Many developed complications from metal debris, high metal ions in their blood, tissue necrosis, pseudotumors, and other systemic medical problems. In 2014 Biomet agreed to a settlement over the M2a and M2a Magnum hips. The attorneys at mctlaw are aggressively litigating on behalf of clients with these hip replacements. “We encourage anyone having problems with their Biomet M2a hip to contact us so we can evaluate your situation and give you preliminary advice about your case,” says Maglio.
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