The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device.
Zimmer Company Background
Zimmer is a worldwide leader in joint replacement solutions for knee pain and hip pain, and provides comprehensive spine care solutions for acute and chronic back pain. The company also provides a broad range of trauma, dental implant, and orthopaedic surgical products. Founded in 1927, Zimmer is committed to providing effective techniques in hip replacement and knee replacement for orthopaedic surgeons who restore mobility and relieve the pain of osteoarthritis and traumatic injuries. Our minimally invasive hip and minimally invasive knee replacement systems and our wide range of related products and services make us valuable partners to health-care providers in more than 80 countries.
Class 2 Recall
The firm, Zimmer, Inc., sent an “URGENT DEVICE CORRECTION” letter dated April 26, 2010, to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to destroy or disregard all previous versions of the surgical technique, review the attached revised surgical technique to familiarize yourself with the modifications and warnings, and complete and return the Health Care Professional Dcoumentation Form via fax to Zimmer, Inc. at (574) 372-4265. (Note: Zimmer made a modification to the surgical technique and instructions for use. They added a warning to fully cement and pressurize the anterior and posterior surfaces of the tibial component, and to strongly recommend the use of a drop down stem extension. This change was completed and approved on April 23, 2010.)
- NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 2, sterile, REF 00-5950-027-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
- The recall affected 68,384 units.
NexGen Knee FDA Overview
Product Name: NexGen® LPS-Flex Mobile Bearing and LPS-Mobile Bearing Knees
PMA Applicant: Zimmer, Inc.
Address: P.O. Box 708, 1800 West Center Street, Warsaw, Indiana 46581
Approval Date: December 10, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060037a.pdf