Field Safety Corrective Action for M2a 38mm Acetabular System
Zimmer Biomet, manufacturer of the device, voluntarily issued a field safety corrective action notice addressed to all European surgeons who may have treated patients with this system.
Why issue a field safety corrective action? Data analyzed at the National Joint Registry for England, Wales and Northern Ireland revealed that the M2a 38mm Acetabular metal-on-metal hip system has a higher than expected revision rate.
What does the notice tell European surgeons? The notice alerts surgeons to the importance of informing patients to the potential risks posed by metal-on-metal hips. It also reminds surgeons that the minimum requirement is to follow up with their patients annually as established in 2012 by the Medicines & Healthcare Products Regulatory Agency (MHRA), the British version of our Federal Drug Administration.
No Warnings Issued in the United States
Last year, the company stopped all sales of the device in Australia, issuing a Hazard Alert based on data from the Australian Orthopaedic Association showing higher than expected revision rates. However, no such alerts or safety warnings have been issued in the United States even though there are thousands of patients with the same device.
If you have the M2a 38mm Acetabular System and your surgeon has recommended a revision surgery for you, talk with a lawyer first. It is essential that you take possession of the implant as soon as it is removed to preserve it as evidence for your case. Pathology specimens may also be needed.
Receive a Free Evaluation from Experienced Metal-on-Metal Hip Attorneys
If you were implanted with a defective metal-on-metal hip system that requires revision surgery, you need attorneys who are experienced in handling cases concerning defective medical products. Contact us today for a free, no-obligation case evaluation.