In September 2010, the FDA issued a recall on one particular Zimmer knee replacement product known specifically as NexGen MIS, (‘Minimally Invasive Surgery’) (not to be confused with other products in the NexGen line for which there has been no recall). The FDA statement is as follows:
NexGen complete knee solution MIS total knee replacement 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). Zimmer NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only. (Certain Model Codes apply and should not be confused with Models and Codes that are not subject to recall.)
Regarding knee implants generally, some makes and models have recently come under increased FDA scrutiny. Common patient complaints that may indicate a failure of any knee replacement, not just Zimmer knee replacements, include: knee pain, radiating pain up and down the leg where knee replacement was performed, swelling, instability, and noticeable warmth of the joint. Not all such indicate a problem with the implant itself and well functioning implants have been a great benefit to the vast majority of patients afflicted with knee problems.
If you or a loved one has undergone Zimmer knee replacement surgery, please contact us for a free, no-obligation consultation to determine whether you have a claim for financial compensation.
If you are uncertain which knee replacement implant or prostheses that you have, we can obtain those medical records for you.
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS RECALL NOTICE
- Zimmer Holdings, Inc. : Zimmer Knee Component Shows New Type Of Failure
DowJones February 6, 2012
NEW YORK -(Dow Jones)- A small percentage of patients who received replacement knee surgeries using a type of component made by Zimmer Holdings Corp. (ZMH) experienced an unexpected problem that can lead to the destruction of the implant, according to the abstract of a single-center study to be presented at a medical meeting this week.
- Surgeon vs. Knee Maker: Who’s Rejecting Whom?
NYTIMES June 19, 2010
IT was a long, fruitful medical marriage that is fast becoming an angry public divorce, one that offers a rare look at a clash between a top-shelf consultant and his corporate patron over patient safety.
- The High Failure Rate of a High-Flex Total Knee Arthroplasty Design
AAOS March 11, 2010
This cementless high-flex femoral component reviewed has a high incidence of failure with 36% being loose and 9.3% having had revision or impending revision for painful loosening.