Zimmer, Inc. was sued in federal court over the Zimmer NexGen Knee System, a family of "high-flex" knee replacement parts. It includes the NexGen CR-Flex, the Gender Solutions Female CR-Flex and LPS-Flex femoral parts, and the MIS Stemmed Tibial Component.
Plaintiffs allege the high-flex parts loosened and failed earlier than a standard implant. They say this caused pain and forced revision surgery to replace the failed parts.
The lawsuits were combined into a federal case known as MDL No. 2272. Judge Rebecca R. Pallmeyer oversaw it in federal court in Illinois. That MDL closed October 8, 2019. It no longer appears on the federal courts' pending-MDL list.
Lawsuit at a glance
- Case or litigation name: In re: Zimmer NexGen Knee Implant Products Liability Litigation, MDL No. 2272
- Defendants: Zimmer, Inc.; Zimmer Holdings, Inc.; Zimmer Orthopaedic Surgical Products, Inc.
- Court and docket number, when available: MDL No. 2272, N.D. Illinois - CourtListener/JPML docket
- MDL number, judge, and case count, when an MDL exists: MDL No. 2272, Judge Rebecca R. Pallmeyer, N.D. Illinois - closed October 8, 2019; off the JPML's current pending list
- Filing date: JPML petition filed June 6, 2011; Transfer Order consolidating 18 actions signed August 8, 2011
- Main allegations: Plaintiffs allege NexGen high-flex femoral components loosen and fail prematurely, forcing revision surgery with no offsetting clinical benefit
- Products or people involved: NexGen CR-Flex and Gender Solutions Female CR-Flex/LPS-Flex femoral components, and the MIS Stemmed Tibial Component; patients implanted who needed revision surgery
Latest Zimmer NexGen Knee Lawsuit Updates
December 6, 2022: Zimmer Recalls a NexGen Tibial Component Tied to LPS Flex
Zimmer Biomet issued recall Z-0467-2023 for the NexGen Option Stemmed Tibial Component after UK joint-registry data showed higher revision rates [1]. The affected pairings were the LPS Flex or LPS Flex GSF femoral parts named in the lawsuits.
The recall covered about 2,092 units and remained open nationwide when this page's source was last read. It ties the tibial part directly to the FDA-cleared high-flex femoral parts named in the lawsuits.
October 6, 2020: New Study Finds Higher Loosening in High-Flex Knees
A 16-year follow-up study published in the Indian Journal of Orthopaedics compared two Zimmer knee designs in the same patients. It looked at NexGen high-flex femoral components against a standard-flex design [2].
The high-flex knees needed revision surgery far more often than the standard-flex knees studied, mainly for aseptic loosening. The authors found no benefit from the added flexion the high-flex design was built to provide.
October 8, 2019: Zimmer NexGen Knee MDL Closes
The MDL that combined the federal Zimmer NexGen knee lawsuits - In re: Zimmer NexGen Knee Implant Products Liability Litigation - closed on October 8, 2019. The court ended the docket that same date.
The case no longer appears on the Judicial Panel on Multidistrict Litigation's current list of pending federal MDL cases. That panel first combined the lawsuits more than eight years ago.
June 27, 2014: FDA Recalls NexGen Tibial Component Lots
The FDA posted recall Z-1934-2014 for the NexGen MIS Total Knee Procedure Stemmed Tibial Component [3]. It covered specific lots: Precoat, Fixed Bearing, Size 4. Zimmer found the threads on those lots could be out of specification.
The recall covered 41,180 units and ended October 29, 2015. The FDA said the cause was an equipment maintenance issue. This was the second of three tibial-component recalls Zimmer issued for this line.
August 8, 2011: Zimmer NexGen Cases Consolidated into an MDL
The panel transferred 18 federal Zimmer NexGen knee lawsuits into one combined pretrial proceeding, acting on a transfer petition filed June 6, 2011. The same judge in the Northern District of Illinois oversaw it.
Plaintiffs filed a master long-form complaint that laid out the design and warning claims against Zimmer on January 12, 2012. Individual cases could then adopt it instead of repeating the same claims [4].
September 13, 2010: FDA Recalls Zimmer NexGen Tibial Component
The FDA posted recall Z-2408-2010, a Class 2 device recall, for the same NexGen tibial component line, four years before the 2014 recall. Zimmer had received 114 device reports of loosening needing revision surgery [5].
The recall covered about 68,384 units distributed worldwide, including 13 U.S. states, and the FDA closed it on March 28, 2011. Zimmer's corrective action was an urgent letter directing surgeons to fully cement the tibial component.
What Is the Zimmer NexGen Knee System?
The FDA calls this device type a knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis [6]. In plain terms, it is an implant that replaces the knee joint. It bonds to bone on its own, without cement.
Zimmer's NexGen "high-flex" femoral components are this device type. The complaint states the FDA cleared them in 1999. It used a substantial-equivalence basis. The complaint states a related, cemented part, the MIS Stemmed Tibial Component, was cleared in 2005.
Who May Be Affected?
People who received a Zimmer NexGen high-flex femoral part may match the circumstances described in these lawsuits. So may people who received the MIS Stemmed Tibial Component. The FDA recalled that component in 2010, 2014, and 2022.
This includes anyone who developed ongoing knee pain, felt the joint loosen, or needed revision surgery to replace the implant. The affected parts include the CR-Flex, the Gender Solutions Female LPS-Flex and CR-Flex, plus the recalled tibial parts.
Matching these circumstances does not guarantee a legal claim. An individual legal review decides that. It looks at the medical records and the state's filing deadline.
Reported Injuries or Damages
Reported harms come from three sources: the lawsuits' own claims, FDA device reports, and independent research. The master long-form complaint alleges the high-flex parts loosen early, causing pain and the need for revision surgery.
Separately, the FDA's 2010 recall record cites 114 device reports of loosening that needed revision surgery. This figure came from the agency itself, not from claims in the lawsuits.
The same 16-year follow-up study found 5 of 30 high-flex knees, or 16.7 percent, needed revision surgery. Loosening was the main cause. None of the standard-flex knees studied needed revision over the same period.
Anyone who needed a second knee surgery for a different implant can read the site's knee replacement revision surgery lawsuit page for related information.
Recall and Regulatory Background
Three FDA recalls involve NexGen tibial parts. Two, in September 2010 and June 2014, covered the MIS Stemmed Tibial Component and have since ended. A third, in December 2022, covered the Option Stemmed Tibial Component and remained open.
The same 2022 recall ties directly to the high-flex femoral parts central to these lawsuits. That is unlike the two earlier tibial-only recalls above.
Evidence to Preserve
Anyone thinking about a claim over a Zimmer NexGen high-flex knee implant should find and keep these records before a legal review:
- The surgical record or the implant's packaging, which shows the exact component name, model, and lot number that was used
- Medical records from before and after the knee replacement surgery, including the doctor's original diagnosis
- Imaging, such as X-rays, that shows the implant loosening, wearing down, or failing over time
- Records of any revision surgery done to remove or replace the implant, plus the date it took place
- Letters, emails, or notes of any calls with Zimmer, a hospital, or a treating surgeon about problems with the device
Together, these records help show which exact component was implanted. They also help show when problems first began and what treatment followed.
Filing Deadlines
Deadlines for filing a product liability claim over a knee implant come from state law, not from this case's own schedule.
How much time a person has depends on where they live and when the injury, or the need for revision surgery, was discovered.
Missing that window can end a claim even when the medical facts are strong. Anyone considering a claim should talk to a lawyer promptly.
Frequently Asked Questions
Who Is Being Sued in the Zimmer Knee Replacement Lawsuits?
The Zimmer knee replacement lawsuits sued three corporate defendants: Zimmer, Inc., Zimmer Holdings, Inc., and Zimmer Orthopaedic Surgical Products, Inc. All three appear on the Master Long Form Complaint that set out the case's core allegations in the federal MDL.
What Are the Signs of Zimmer NexGen Knee Failure?
Signs of Zimmer NexGen knee failure include ongoing knee pain, a loose or unstable joint, and less range of motion. The 16-year follow-up study used X-rays and the Knee Society Roentgenographic Evaluation and Scoring System. It checked for radiolucent lines, a loosening sign, around the implant.
What Does the Research Say About Zimmer NexGen High-Flex Knees?
The research on Zimmer NexGen high-flex knees includes a 16-year study of 60 patients. By the final follow-up, 16 had died of unrelated causes and 15 were lost to follow-up. Five high-flex knees had already been revised, leaving 24 knees - 40% of the original 60 - for final evaluation.
What Is the Difference Between the Zimmer NexGen CR and CR-Flex Components?
The Zimmer NexGen CR and CR-Flex components differ in range of motion and fixation. The CR uses a standard design, while the CR-Flex was built for deeper bending and skips bone cement, attaching directly to the thighbone. That uncemented, high-flex design is the one named in the lawsuits.
What Should I Do If I Think My Zimmer NexGen Knee Implant Is Failing?
If a Zimmer NexGen knee implant seems to be failing, see a doctor for an evaluation and imaging. Zimmer Biomet's customer service line, 574-371-3071, can help confirm whether an exact device falls under any of its recalls.
Is It Too Late to File a Zimmer Knee Replacement Lawsuit?
It is not automatically too late to file a Zimmer knee replacement lawsuit. That is true even though the federal MDL that combined earlier cases has closed. A new claim would now be an individual filing in state court. Whether it is still timely depends on that state's deadline.
References
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=196677
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8149562
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=127984
- https://www.ilnd.uscourts.gov/_assets/_news/zimmer/211.pdf
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92117
- https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/knee-joint-patellofemorotibial-and-femorotibial-metalpolymer-porous-coated-uncemented-prostheses