Zimmer NexGen MIS Knee Replacement Lawsuit
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 Zimmer NexGen MIS Statement
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.