Total knee replacement is one of the most common orthopedic surgeries performed today, and most implants last for many years. In some patients, an implant loosens, wears out, or becomes infected, and revision surgery becomes necessary.
Several manufacturers have knee-implant components tied to premature failure and revision surgery. These include Zimmer Biomet, DePuy Synthes, Stryker, Exactech, and Arthrex. Patients allege the components were defectively designed or made.
No single case covers every brand. The Zimmer NexGen cases, consolidated as MDL No. 2272, closed in 2019, while a separate Exactech proceeding, MDL No. 3044, remains active, and other claims proceed as individual lawsuits.
Lawsuit at a glance
- Case or litigation name: No single case: two verified MDLs, 2272 (Zimmer NexGen, closed) and 3044 (Exactech, active)
- Defendants: Zimmer Biomet, DePuy Synthes, Stryker, and Arthrex, each with an FDA recall, plus Exactech, an MDL No. 3044 defendant
- Court and docket number, when available: N.D. Illinois (MDL 2272, closed); E.D.N.Y. (MDL 3044, active)
- MDL number, judge, and case count, when an MDL exists: 2272: Judge Pallmeyer, terminated October 8, 2019. 3044: Judge Garaufis, active since April 12, 2024
- Filing date: MDL 2272 filed June 6, 2011. MDL 3044 transfers ongoing, latest April 12, 2024
- Main allegations: Design or manufacturing defects causing premature loosening, wear, or component failure requiring revision surgery
- Products or people involved: Patients whose implant was a recalled Zimmer, DePuy, Stryker, or Arthrex component, or an Exactech MDL 3044 component
Latest Knee Replacement Revision Surgery Lawsuit Updates
April 12, 2024: Panel Sends Another Exactech Case to MDL No. 3044
The Judicial Panel on Multidistrict Litigation issued a transfer order moving another Exactech knee-implant case into MDL No. 3044 [1].
The case joins other Exactech claims coordinated before Judge Nicholas G. Garaufis in the Eastern District of New York. Coordinated pretrial proceedings let the court handle shared fact questions once, rather than repeating discovery in every case filed nationwide.
February 22, 2021: DePuy Recalls Attune Tibial Base Lots
DePuy Synthes recalled 37 lots of ATTUNE(S+) Tibial Bases, about 102 units worldwide [2]. The company acted after finding that some packaging had been damaged before it reached hospitals. The FDA logged the action as recall Z-1314-2021.
Damaged packaging can break the sterile barrier around an implant. This is why the FDA classified this a Class 2 recall rather than a routine update.
October 8, 2019: Zimmer NexGen MDL Closes
The Zimmer NexGen multidistrict case, MDL No. 2272 in the Northern District of Illinois, was closed after years of coordinated pretrial work before Judge Rebecca R. Pallmeyer [3].
The docket had run since June 2011, when the panel first consolidated NexGen high-flex knee cases for coordinated pretrial handling. Claims against other manufacturers named on this page were never part of MDL No. 2272.
March 22, 2017: Zimmer Recalls Regenerex Patella Components
Zimmer Biomet recalled 8,154 Regenerex Patella components sold in the US and Canada. The recall followed reports that the pegs used to anchor the implant were shearing after surgery.
FDA records list this as recall Z-2068-2017 [4], closed that October. Sheared pegs can leave the patella component unstable, a mechanical failure separate from the loosening allegations raised in the NexGen case above.
December 17, 2015: Arthrex Recalls iBalance Tibial Trays
Arthrex recalled 2,378 iBalance TKA Tibial Trays after the metal surface texture did not match the intended design [5]. This mismatch raised the risk that the tray would loosen from the surrounding bone.
FDA records show this as recall Z-1195-2016, covering nationwide distribution across 29 states before it closed the following December. This is consistent with the loosening problems described in Reported Injuries or Damages below.
May 5, 2006: Stryker Recalls Mislabeled Duracon Inserts
Stryker's Howmedica Osteonics unit recalled a small batch of Duracon Total Knee tibial inserts [6]. Some boxes labeled 11mm actually held a 9mm insert instead, a mismatch that could affect how the implant fits.
This recall appears in FDA records as Z-1601-2009. It was limited to accounts in five states that had already received the mislabeled inserts. This was a labeling error rather than a device defect.
What Is Revision Total Knee Replacement?
A revision total knee replacement is a second surgery performed when a knee replacement fails. The surgeon removes some or all original implant parts and replaces them with new ones, per the American Academy of Orthopaedic Surgeons [7].
Who May Be Affected?
You may be affected if you received a total knee replacement that later loosened, wore prematurely, or failed. That failure would have required revision surgery.
Over 700,000 total knee replacements are performed in the US each year. Even a small failure rate affects many patients [8].
This is especially relevant if your original implant matches one of the four FDA-recalled components covered in the Latest Updates above. It is also relevant if your implant was an Exactech component named in the active MDL No. 3044 litigation.
Each recall notice lists lot numbers and dates that a surgeon's office or hospital record can match against your own implant card.
Not every implant failure traces back to a manufacturer defect. An individual legal review is the only way to match your specific implant, symptoms, and records against a verified defect or recall.
Reported Injuries or Damages
Implant loosening, joint instability, and infection are documented reasons a knee replacement needs revision. So is polyethylene wear, which leads to bone loss around the implant.
In the Zimmer NexGen litigation, plaintiffs alleged that the high-flex femoral components failed at a higher rate than standard-flex devices [9]. They claimed the added risk carried no offsetting clinical benefit.
The complaint cites a study presented at a 2010 orthopedic surgeons' meeting comparing failure rates between high-flex and standard-flex components. Zimmer disputed the findings and blamed surgical technique rather than the device.
These are complaint allegations and a cited study's findings, not confirmed causation for every patient. The FDA recalls above are separate, agency-classified actions with their own documented reasons.
Recall and Regulatory Background
Four FDA device recalls documented on this page cover components from Zimmer Biomet, DePuy Synthes, Stryker, and Arthrex. They span a mislabeled 2006 tibial insert to an active 2021 packaging recall.
Reasons include shearing pegs, nonconforming surfaces, and damaged sterile packaging, each classified separately by the FDA. A recall does not automatically establish liability.
It confirms only that the FDA classified a manufacturing or labeling problem. For claims specific to the Zimmer NexGen device, see the Zimmer knee replacement lawsuit page.
Evidence to Preserve
Strong knee-implant claims rest on records gathered early, before facilities purge old files or components are lost. Keep the following:
- Medical records: the original surgery report, every follow-up visit, and any revision-surgery records.
- Implant identification: the sticker or card naming the brand, model, and lot number given at surgery.
- Symptom records: dated notes on pain, swelling, instability, or other problems as they began.
- Expense records: bills, insurance statements, and pay stubs showing missed work.
- Manufacturer notices: any recall letter or safety notice you or your doctor received about the device.
These records let a lawyer confirm which manufacturer and model were implanted. The lawyer can then match your timeline against the recall dates and study findings described above.
Filing Deadlines
Every state sets its own deadline for filing a product-liability claim. The applicable rule depends on where you live and which state's law governs your case.
The clock often starts on the date of injury. Some states instead count from the revision-surgery date or the date a defect was discovered.
Missing that deadline can end a claim even when the underlying facts are strong. Anyone considering a claim should check it with a lawyer promptly.
Potential Compensation
Knee-implant claims typically seek categories of damages tied to the injury. These include medical expenses for the revision surgery and related care, lost income during recovery, and pain and suffering.
Compensation amounts vary by case. Past results do not guarantee future outcomes. Potential compensation may also depend on whether a claim proceeds individually or through the active Exactech MDL litigation.
Frequently Asked Questions
Was My Doctor or the Implant Manufacturer Responsible for My Knee Injuries?
Whether your doctor or the implant manufacturer is responsible for your knee injuries usually depends on what caused the failure. Most claims target the manufacturer over a device defect, and a claim against a doctor needs separate proof of a surgical mistake.
How Long Does a Knee Replacement Lawsuit Take?
How long a knee replacement lawsuit takes varies by case. An individual claim may resolve in months. A case folded into an MDL often takes years as the court coordinates shared evidence before individual claims proceed toward resolution.
What Does the Research Say About Knee Implant Failure Rates?
The research on knee implant failure rates cited in the Zimmer NexGen complaint includes a 2010 study by Dr. Richard Berger and Dr. Craig Della Valle finding nearly 10% of the high-flex devices they implanted had failed. Zimmer disputed the findings.
Which Knee Replacement Brands Have Been Named in Lawsuits?
The knee replacement brands named in lawsuits and FDA recalls checked for this page include Zimmer Biomet (Regenerex), DePuy Synthes (Attune), Stryker (Duracon), and Arthrex (iBalance). Zimmer's NexGen line was also the subject of a separate, now-closed multidistrict case, detailed in the update above.
Is the Zimmer NexGen Knee Lawsuit Still Active?
No, the Zimmer NexGen knee lawsuit, MDL No. 2272, is not still active. The case ran for about eight years before the court closed it on October 8, 2019. No new claims are being added to it, though patients with other affected brands may still pursue individual claims separately.
Can I File a Class Action for My Knee Replacement Complications?
Filing a class action for knee replacement complications is uncommon. These cases are typically filed as individual lawsuits. In the Zimmer NexGen MDL, each plaintiff proceeded under a shared Master Long Form Complaint. Damages were still evaluated case by case rather than as one certified class.
References
- https://www.jpml.uscourts.gov/sites/jpml/files/MDL-3044-Transfer_Order-3-24.pdf
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=186020
- https://www.courtlistener.com/docket/1052139/in-re-zimmer-nexgen-knee-implant-products-liability-litigation/
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154964
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143925
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74712
- https://orthoinfo.aaos.org/en/treatment/revision-total-knee-replacement/
- https://orthoinfo.aaos.org/en/treatment/total-knee-replacement
- https://www.ilnd.uscourts.gov/_assets/_news/zimmer/211.pdf