U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Product mix-up.
the avenir m¿ller stem 6 lateral uncemented might be placed in the packaging of the avenir m¿ller stem 4 standard uncemented and vice versa.
potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.
조치
Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 30, 2016 to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification immediately and ensure affected personnel are aware of the contents and assist Zimmer Biomet sales representative with the quarantine of any affected device. Your Zimmer Biomet sales representative will remove any affected device. Customers were also instructed to complete the Certification of Acknowledgement form and return to corporatequality.postmarket@zimmerbiomet.com. Customers with further questions or concerns were instructed to contact the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.
For questions regarding this recall call 800-348-2759.
Avenir M¿ller Stem 4 Standard || Avenir M¿ller Stem 6 Lateral || Hip joint metal/ceramic/polymer semi-constrained cemented or || nonporous uncemented prosthesis || Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only.
“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.