If you have had a knee replacement and received a Zimmer NexGen MIS, LPS-Flex, or CR-Flex Knee Implant you may be entitled to compensation, contact us for a free case consultation and evaluation. Call 1-800-448-0883 or submit a case evaluation form.
At the March 2010 national meeting of the American Academy of Orthopaedic Surgeons, researchers, Dr. Richard Berger and Dr. Craig Della Valle, both former consultants for Zimmer, Inc. and surgeons from Rush University Medical Center in Chicago, presented evidence of a higher than expected failure rate, indicating a need for a recall, of the Zimmer NexGen CR-Flex Porous Femoral Knee Replacement. Dr. Berger’s study looked at 108 patients who received the Zimmer NexGen CR-Flex Knee Replacement System. This particular knee replacement attaches to the thigh bone without cement. It was designed to fuse together the device with the thigh bone through bone growth. However, Dr. Berger’s data indicates that the Zimmer NexGen CR-Flex Knee Replacement part does not fully fuse together with the bone instead becoming loose over time or completely detaching. Dr. Berger and Dr. Della Valle found that 36% of the patients who received the Zimmer NexGen CR-Flex had signs of knee loosening and implant failure. The data further suggested that the 9% of patients with the Zimmer NexGen CR-Flex Knee Replacement System required revision surgery.
Zimmer denied these claims, but since then has worked with the FDA to issue two recalls of their Zimmer NexGen knee replacement products. On April 26, 2010, Zimmer sent an “URGENT DEVICE CORRECTION” letter to all customers about the Zimmer NexGen Complete Knee Solutions MIS knee. Then on September 13, 2010, the Food and Drug Administration (FDA) posted a Class 2 Recall for the Zimmer NexGen Complete Knee Solutions Minimally Invasive Surgery (MIS) Tibial Components, Locking Screw and Stem Extensions. Zimmer reported that this Zimmer NexGen recall was due to the number of knee replacement complaints of implanted device loosening and requiring revision surgery.
Then on December 2, 2010, the FDA issued another Class 2 Recall for the Zimmer NexGen Knee Replacement. This recall was for the Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component and Zimmer NexGen Complete Knee Solution LPS Femoral Component. This December 2010 Recall was due to the Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Gender Femoral Component exhibiting a “nonconforming internal CAM radius.”
- Knee Complication and Knee Pain
- Loosening of Replacement Knees
- Knee Implant Failure
- Revision Surgery
- Restriction of Daily Activities
- Diminished Range of Knee Motion
If you are experiencing any of these symptoms, you may be entitled to compensation. Contact Fleming | Nolen | Jez, L.L.P. for a free case consultation and evaluation. Call 1-800-448-0883 or submit a case evaluation form.
On the Web: More Zimmer Knee Replacement Information
- FDA Class 2 Recall: Nexgen Complete Knee Solution MIS Tibial Components, Locking Screw and Stem Extensions
- FDA Medical & Radiation Emitting Device Recalls
- Surgeon vs. Knee Maker: Who’s Rejecting Whom?, New York Times
- Senator Seeks Data on Artificial Hips and Knees, New York TImes
- Adult Reconstruction Knee 3: Outcomes of Total and Unicompartmental Knee Replacements
- Zimmer NexGen CR-Flex Knee: Medical Devices & the 510(k) Approval Process
- Zimmer NexGen High-Flex Knee Replacement Law Suits:
Multi-District Litigation
- Zimmer NexGen Knee Replacement MDL Contemplated
