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.
After evaluation of 13 complaints(0.4% rate) for hyper-extension of the zimmer segmental system, zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
조치
Depth of recall
" Notifications were sent to customers, surgeons and risk managers, which use the affected product. Distributors were also informed of the notifications sent to surgeons and risk managers. The customers were identified by performing an invoice search and distribution history for the Polyethylene Inserts (00-5850-012-95 and 00-5850-013-95) since product launch.
Recall Communication
" All distributors were notified via electronic mail. Distributors that have received affected inventory were also notified via courier. Hospital risk managers and surgeons were also notified via courier.
On 12/19/13, hospital risk managers and surgeons were provided with a notification identifying the issue and their responsibilities. These responsibilities include ensuring the affected personnel are aware of the contents of the notification.
On 12/19/13, Distributors were sent a notification identifying the issue and to provide a copy of the notification sent to surgeons and risk managers. The distributors will also be instructed as needed to assist with identifying a comprehensive list of surgeons.
" Communications outside of the United States will occur approximately two weeks after the United States communications.
Effectiveness Checks
Zimmer will conduct effectiveness checks in the following way:
"Surgeons/Hospitals
o100% of the FedEx notifications will be accounted for.
oSecond and third notification attempts will be made.
oFailed delivery attempts following the third attempt will result in the account being deemed as nonresponsive.
Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
제품 설명
Zimmer Segmental Systems; Polyethylene Inserts, Size B. || Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
“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.