Exactech Class Action
In September 2024, Gerard Malouf & Partners commenced a class action in the Federal Court of Australia against Exactech Australia Pty Ltd and Exactech Inc. This class action was filed on behalf of group members affected by the manufacture and supply of faulty knee, hip, and shoulder implants.
This proceeding follows the widespread recall of thousands of Exactech joint replacement devices. If you have received an Exactech implant, you may be eligible for compensation.
GMP Law is committed to seeking justice for those impacted by these defective medical devices. Our class action team is working to hold Exactech accountable and to secure compensation for those who have suffered complications or required revision surgery as a result of these implants.
Current status
Are you among those affected by the wrongdoing of corporations or institutions, and as a result, suffered loss or injury? You don’t have to face this challenge alone.
At GMP Law, we have extensive experience in class action lawsuits, amplifying the voices of individuals who have experienced similar harms or losses. By joining forces, we can hold corporations and institutions accountable and seek the justice you deserve.
Initiated
On 5 September 2024, Gerard Malouf & Partners commenced a representative proceeding in the Federal Court of Australia against Exactech Australia Pty Ltd ACN 146 150 754 (Exactech Australia) and Exactech Incorporated (Exactech US).
We launched the class action in Australia in 2024 following Exactech’s recall of defective knee, hip and shoulder implants.
Progress
On 29 October 2024, Exactech Inc. commenced bankruptcy proceedings in the United States Bankruptcy Court. During this filing, it was revealed that Exactech Inc. intended to place the Australian Exactech entity into administration within 75 days.
On 23 December, 2024, GMP Law obtained carve-out orders to protect the progress of Australian class action.
On 6 February, 2025, the Federal Court of Australia formally recognised Exactech’s bankruptcy proceedings. As a result, the Court made orders staying any legal proceedings in Australia against Exactech US. Despite this development, settlement negotiations continued.
Settlement reached
On 30 May 2025, the Federal Court of Australia approved the distribution and publication of the Opt Out and Settlement Notice. The Court has ordered that this Notice be published for the information of Class Members.
The Notice provides information about the proposed settlement of A$8,700,000 (Settlement Sum) and about the options available to Class Members to register to participate in the settlement or to opt out of the class action.
Class members have until 10 July 2025, to support or object to the proposed settlement, or to opt out of the class action if any member does not wish to remain a Class Member.
The Settlement Approval hearing is scheduled for 22 July 2025.
Below are the key timelines:
- Support or objection period: Class members can support or object to the proposed settlement by 4:00pm on 10 July 2025.
- Opt-out period: If you do not wish to be part of the class action, you have until 4:00pm on 10 July 2025, to opt out of the class action and, if you opt out, you will not be bound by, or entitled to a share in the benefit of the settlement (Class Deadline) .
- The Settlement Approval hearing: On 22 July 2025, the Federal Court will consider whether the settlement, including any deductions for legal costs and the proposed method for distributing funds is fair and reasonable.
- Registration for Compensation: If the Court approves the settlement, eligible class members must register to receive their share of the settlement.
Important Documents
Important notice regarding your legal rights
Opt Out and Settlement Notice
Simon Harrold v Exactech Australia Pty Ltd ACN 146 150 754 & Anor Federal
Court Proceedings NSD 1224/2024
An important public notice has been published by the order of the Federal Court of Australia about the Exactech class action concerning defective knee, hip and shoulder implants made by Exactech.
If you had joint replacement surgery between 2003 and 2024 involving an Exactech device, you may be eligible under the proposed settlement.
The abovementioned notice explains the settlement and your rights, including how to opt out if you do not wish to be a part of it.
Important documents
Key developments
In 2021 and 2022, the Australian Therapeutic Goods Administration issued a recall of the Exactech defective inserts due to pre-operative storage issues. The devices were packaged in a way that exposed them to oxidation which degraded the integrity of the implants.
The scope of this issue is significant and global:
- In Australia, we commenced the class action in 2024, estimating that up to 7,000 people may have been affected by these allegedly defective implants.
- In the United States, a class action claim against Exactech was also filed. While the matter has progressed significantly, it has not been resolved due to the bankruptcy proceedings.
In late 2024 and early 2025, several significant developments occurred:
- Mediation: A mediation session was held on 20 December 2024. While a settlement was not reached, the parties agreed to resume mediation in February 2025.
- Bankruptcy proceedings: On 29 October 2024, Exactech Inc. filed for bankruptcy on the United States indicating plans to place the Australian entity into administration.
- Model Law stay: On 6 February 2025, the Federal Court of Australia recognised the U.S. bankruptcy and stayed proceedings against Exactech, whilst settlement negotiations continued.
In May 2025, a settlement agreement was reached:
- Settlement agreement: Following successful settlement negotiations through early 2025, the parties reached a proposed settlement of A$8,700,000, subject to Court approval.
- Court orders: On 30 May 2025, orders were made approving the Opt-Out and Settlement Notice to be distributed to all group members, with key deadlines set for July 2025.
About the class action
This class action concerns serious allegations that Exactech failed to ensure the safety and quality of its hip, knee, and shoulder implants. These alleged failures resulted in unexpected complications for many patients who had a joint replacement surgery.
The class action is seeking remedies for group members under the Australian Consumer law for:
Product liability: Exactech is accused of producing and distributing defective medical devices.
Negligence: Failure to properly test and ensure the safety of their products before distribution.
The TGA recall relates to Exactech hip, knee, and shoulder replacement implants.
Specifically, the following devices are included in the recall:
- Optetrak and Optetrak Logic knee replacement systems.
- Truliant knee replacement systems.
- Novation and Acumatch hip implants.
These components were widely used in joint replacement surgeries for over two decades.
Patients with the recalled implants have reported severe complications such as:
- Accelerated wear of the implant components
- Bone loss (osteolysis) around the implant
- Component loss or instability, including fatigue cracking or fracture
- Noise from the joint during movement
- Loss of osseointegration (fusion between the implant and the bone)
- Joint pain and swelling
- Infection
- Decreased range of motion.
These complications can significantly impact a patient’s quality of life and may necessitate revision surgery.
The defective implants have led to various health issues for affected patients:
- Chronic pain: Many patients report persistent pain that affects their daily activities
- Reduced mobility: Instead of improved mobility, some patients experience limitations in their joint function
- Need for revision surgery: Many affected individuals require additional surgeries to remove and replace the faulty implants
- Increased risk of infection: Revision surgeries carry a higher risk of infection compared to initial joint replacements
- Tissue and bone necrosis: Some patients have experienced death of tissue and bone around the implant
- Chronic inflammation: Ongoing inflammatory responses have been reported in affected areas
- Psychological distress: The uncertainty and physical challenges have led to anxiety and depression for some patients
- Economic burden: Patients face additional medical expenses and potential loss of income due to extended recovery periods.
What’s next?
Below are the key timelines:
- Support or objection period: Class members can support or object to the proposed settlement by 4:00pm on 10 July 2025.
- Opt-out period: If you do not wish to be part of the class action, you have until 4:00pm on 10 July 2025, to opt out of the class action and, if you opt out, you will not be bound by, or entitled to a share in the benefit of the settlement (Class Deadline) .
- The Settlement Approval hearing: On 22 July 2025, the Federal Court will consider whether the settlement, including any deductions for legal costs and the proposed method for distributing funds is fair and reasonable.
- Registration for compensation: If the Court approves the settlement, eligible class members must register to receive their share of the settlement.
Are you eligible for compensation?
You may be eligible to join the class action and claim compensation if:
- You have been inserted with Exactech’s knee, hip and shoulder inserts.
- Your device was inserted between the period commencing 1 January 2003 and 5 September 2024.
- You have experienced any health issues that may be related to the Exactech insert.
Even if you haven’t experienced complications yet, you may still be eligible if you have an affected Exactech implant.
To determine your eligibility and join the class action:
- Check if your insert is an Exactech device, if you are not sure you can contact your surgeon, hospital or GP for more information.
- Gather any medical records related to your device and any subsequent issues.
- Register for the class action with GMP Law.
Risk-free participation
There is no financial risk in registering with our firm and becoming a class member. We operate on a No Win No Fee basis. You will not incur any legal fees unless we win your case. If successful, the court may order the defendant to cover your legal fees and out-of-pocket expenses.
If the claim is unsuccessful, you will not be personally liable for any costs.
Take action today to ensure your rights are represented and to pursue the compensation you deserve.
