Exactech Joint Replacement Lawsuit
Plaintiffs allege that Exactech's hip, knee, and ankle replacement components were packaged in defective bags that allowed oxygen exposure, causing the polyethylene to degrade and fail prematurely. The packaging defect went undetected for nearly two decades.
Key Takeaways
- Over 1,800 cases pending as of May 2026
- Defective packaging went undetected for nearly 18 years (2004-2022)
- Three joint types affected: hip, knee, and ankle replacements
- FDA issued Class II recalls for affected products
- Packaging allowed oxygen to degrade polyethylene, causing premature implant failure
Key Facts (May 2026)
| Pending Lawsuits | 1,838 cases in federal MDL |
| Total Cases (Historical) | 1,847 cases filed |
| Affected Products | Hip (GXL), Knee (Optetrak), Ankle (Vantage) |
| Defect Period | ~2004 through 2021-2022 recalls |
| Initial Recall (Knee/Ankle) | August 30, 2021 |
| Expanded Recall (Hip) | February 7, 2022 |
| FDA Classification | Class II Recall |
| Presiding Judge | Hon. Nicholas G. Garaufis (E.D.N.Y.) |
| MDL Established | October 2022 |
| Status | Actively Recruiting |
Case Tracking - 2025
Case count has remained stable with a 0% change in 2025. Bellwether selection is underway as litigation progresses.
Source: JPML MDL Statistics Reports, February 2025-May 2026
1 What Is This Lawsuit?
This litigation involves patients who received hip, knee, or ankle replacement implants manufactured by Exactech, a Florida-based orthopedic device company. Plaintiffs allege that defective packaging allowed oxygen to degrade the polyethylene components before implantation.
The Core Defect
Exactech discovered that vacuum packaging bags for their polyethylene implant components lacked an oxygen barrier layer. This allowed oxygen to penetrate during shelf storage, causing oxidation that degrades the plastic before it's even implanted. The defect dates back to approximately 2004.
Oxidized polyethylene wears faster than normal, generating microscopic debris particles. The body's immune response to these particles causes osteolysis (bone loss), leading to implant loosening, pain, and the need for revision surgery.
2 Recalled Products
GXL Acetabular Liners
Connexion GXL polyethylene liners including NOVATION, ACUMATCH, and ALTEON system components. Various sizes (28mm, 32mm, 36mm).
Optetrak Knee System
OPTETRAK Comprehensive Knee System, all-polyethylene UNI tibial components, RBK PS tibial components, and multiple patella configurations.
Vantage Total Ankle System
Vantage Total Ankle System polyethylene bearing components.
3 How Implant Failure Occurs
The failure process follows a predictable sequence from packaging defect to revision surgery:
Oxidation During Storage
Oxygen penetrates defective packaging and degrades polyethylene before implantation, reducing mechanical strength and increasing brittleness.
Accelerated Wear
Compromised polyethylene wears faster than normal during joint movement, generating microscopic debris particles.
Osteolysis (Bone Loss)
The body's immune system reacts to polyethylene particles, triggering inflammation that causes progressive bone loss around the implant.
Implant Failure
Component loosening, instability, and pain require revision surgery to replace the implant—a more complex procedure than the original.
4 Warning Signs & Revision Risks
Warning Signs of Failure
- Increasing pain with activity or at rest
- Joint instability or "giving way"
- Grinding or clicking sounds
- Swelling and decreased range of motion
Revision Surgery Risks
- Higher infection rates than primary surgery
- Greater blood loss and longer operating time
- May require bone grafting if osteolysis is severe
- Extended recovery (6-12+ months)
5 Key Timeline
Non-conforming bags without oxygen barrier layer enter production—undetected for nearly two decades
Exactech recalls OPTETRAK and Vantage polyethylene components
GXL Acetabular Liners added to recall
Cases consolidated in E.D. New York before Judge Nicholas G. Garaufis
Bellwether case selection underway
6 Who May Have a Claim
Potential Eligibility
- Received hip with GXL liner (2004-2022)
- Received knee with Optetrak (2004-2021)
- Received ankle with Vantage (2004-2021)
- Experiencing symptoms of failure
- Required or may require revision surgery
Important Notes
Confirm Your Implant: Check surgical records or contact your surgeon to verify you received an Exactech implant.
Recall Notice: If you received a notification letter, this confirms you may have an affected device.
Time Limits: Statutes of limitations vary by state (typically 2-6 years).
7 Frequently Asked Questions
How do I know if I have an Exactech implant?
Do I need revision surgery if I have a recalled implant?
What is a Class II recall?
What is 510(k) clearance?
How long do I have to file a lawsuit?
What compensation may be available?
Sources & References
4 official sources citedJudicial Panel on Multidistrict Litigation (JPML) — Official MDL statistics
FDA Medical Device Recall Database — Recall Event IDs 88570, 90279
American Academy of Orthopaedic Surgeons (AAOS) — Joint replacement information
Wilhelm SK, et al., "Polyethylene in total knee arthroplasty," J Orthop Surg. 2018. PMID: 30369289
Data current as of May 2026.
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Every case is unique, and results depend on the specific facts and circumstances involved. Past settlement amounts and case outcomes do not guarantee similar results in your case. If you believe you have a legal claim, you should consult with a licensed attorney in your jurisdiction who can evaluate your specific situation.