Injury guide

Exactech Implant Pain: Signs to Tell a Doctor

New pain, swelling, grinding or trouble putting weight on an Exactech joint? Tell your doctor.

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Updated Oct 5, 202622 sources

This may apply to you if

  • Check the actual model, serial number and applicable recall with your care team.
  • Gather records of symptoms, treatment and any prior surgery or claim filing.
  • Ask which legal process, proof rules and deadline apply to your file.

What the public record says

These are cited sources. Their inclusion does not imply that they endorse People’s Justice or reviewed this page.

The evidence and its limits

Hospital for Special Surgery · The Bone & Joint Journal · 2023

Mid-term survivorship of primary total knee arthroplasty with a specific implant

Design:
Cohort
Participants:
7,941 Optetrak primary knee replacements (2010 to 2018); 369 later revisions reviewed.
Finding:
About 86% of knees were free of any revision at 10 years. Plastic wear, bone loss and loosening were found in 209 of 369 revisions.
Main limitation
Retrospective study at one hospital with no comparison group in the abstract; it describes a group, not any one patient.

Read the source: Mid-term survivorship of primary total knee arthroplasty with a specific implant (opens in a new tab) · Checked Oct 5, 2026

Southern Joint Replacement Institute, Nashville · Arthroplasty Today · 2023

High rates of aseptic loosening in modern posterior-stabilized femoral components from a single manufacturer

Design:
Cohort
Participants:
896 knee replacements (432 Optetrak Logic, 464 Truliant) in 671 patients.
Finding:
17 knees were revised for a loose thigh-bone part. Patients often had pain and repeated swelling, and in more than half, plain X-rays showed no sign of loosening.
Main limitation
Retrospective review from one practice; the authors say counting only revisions may understate loosening.

Read the source: High rates of aseptic loosening in modern posterior-stabilized femoral components from a single manufacturer (opens in a new tab) · Checked Oct 5, 2026

Hospital for Special Surgery · Arthroplasty Today · 2020

Early failure of a modern moderately cross-linked polyethylene acetabular liner

Design:
Other study design
Participants:
204 hip replacements by one surgeon; 5 cases of severe wear described.
Finding:
Five patients developed severe liner wear and bone loss within five years, after years without pain.
Main limitation
Small case series from one surgeon, published before the packaging cause was announced; the authors said the cause was unknown.

Read the source: Early failure of a modern moderately cross-linked polyethylene acetabular liner (opens in a new tab) · Checked Oct 5, 2026

The short answer

What is the problem with recalled Exactech implants?
Many plastic parts were packed in bags missing an extra oxygen barrier. Over time, the plastic can wear down faster. That does not mean every implant will fail. [1]
What signs should I tell my doctor about?
Tell your doctor about new or worse pain or swelling. Also mention grinding or other noise, weakness, or trouble putting weight on the joint. [1]
How is a failing implant diagnosed and treated?
Your doctor may start with an exam and X-rays. Blood tests can check for infection. Other scans may follow if the first tests raise questions. [14]
What does the research say about Exactech implants?
Studies found early wear and loose parts in some Exactech knees and hips. They do not show that your own implant will fail. Your exam and tests matter most. [15]

What rules a case out

Not covered by this case

  • This page cannot tell you whether your implant is failing. A doctor has to examine you.
  • A recall notice alone is not a reason for surgery.

The process

What happens next

  1. 01

    You answer a few questions

    About two minutes. Nothing is sent until you agree on the last step and press submit.

  2. 02

    A lawyer looks at it

    A lawyer at the firm reads your answers and checks them against the current case criteria.

  3. 03

    The firm decides and gets in touch

    If the firm takes your case, you get the terms in writing to read before you sign. You can always say no.

When it fits this case

  • Check the actual model, serial number and applicable recall with your care team.
  • Gather records of symptoms, treatment and any prior surgery or claim filing.
  • Ask which legal process, proof rules and deadline apply to your file.

New pain, swelling, grinding or trouble putting weight on an Exactech joint? Tell your doctor. A recall alone does not mean your implant has failed.

What is the problem with recalled Exactech implants?

Many plastic parts were packed in bags missing an extra oxygen barrier. Over time, the plastic can wear down faster. That does not mean every implant will fail.

FDA says the bags lacked an extra layer that blocks oxygen. Oxygen can change the plastic over time, a process called oxidation. FDA says this can speed up wear and lead to cracked parts. It can also lead to a second surgery.

FDA says the parts in these bags were made from 2004 to August 2021. Knee, hip and ankle implants were affected. Exactech had more packing recalls in 2023 and 2024. Our recall details page lists the product names.

What signs should I tell my doctor about?

Tell your doctor about new or worse pain or swelling. Also mention grinding or other noise, weakness, or trouble putting weight on the joint.

FDA gives this list for anyone with an Exactech knee, hip or ankle implant. You do not need a recall letter to ask. Note when each sign started and what makes it worse. These signs can have other causes, so a doctor needs to examine you.

The orthopedic surgeons’ group AAOS says a failing knee implant can become painful and swollen. It may also feel stiff or unstable. AAOS adds that an infection around an implant can show up months or even years after surgery.

How is a failing implant diagnosed and treated?

Your doctor may start with an exam and X-rays. Blood tests can check for infection. Other scans may follow if the first tests raise questions.

AAOS lists X-rays, bone scans, MRI or CT scans, blood tests and testing fluid from the joint. In one study of Exactech knees, more than half of the patients with a loose part had no sign of it on plain X-rays. Ask whether more tests make sense if your pain does not go away.

Treatment depends on what the tests show. FDA asks doctors to discuss a second surgery case by case. It does not recommend surgery to remove an Exactech implant that works well and causes no symptoms.

What does the research say about Exactech implants?

Studies found early wear and loose parts in some Exactech knees and hips. They do not show that your own implant will fail. Your exam and tests matter most.

Researchers at the Hospital for Special Surgery followed 7,941 Optetrak knees placed from 2010 to 2018. An estimated 86% had not needed another surgery after 10 years. In 209 of the 369 knees that were revised, surgeons found a pattern of plastic wear, inflammation, bone loss and loose parts.

A Nashville practice found that 17 of 896 Optetrak Logic and Truliant knees were redone because a part came loose. Patients often had knee pain and swelling that kept coming back. In a hip report, 5 of 204 hip replacements with one Exactech liner had severe wear and bone loss within five years.

Each of these studies looked back at patients from one hospital or practice. They describe groups of people, not you. They cannot predict how your implant will do.

Who may qualify for a claim review?

A lawyer can review your records if you have an Exactech implant and a problem with it. Signs alone do not decide a claim. Ask what proof is needed.

Exactech’s bankruptcy plan sent injury claims against the company to a trust. The trust’s claim rules ask for proof that you received an Exactech device. Our bankruptcy claims page explains how that works and what is still unknown.

What records should I keep?

Keep your surgery notes, implant labels, X-rays and visit notes. Write down when each sign started. Ask the hospital for any copies you are missing.

Exactech’s online check asks for the serial number of your part. Your surgeon or hospital may have it in your implant record. HHS says you have the right to copies of your medical and billing records, with few exceptions. A provider may charge the reasonable cost of copying and mailing them.

Find out where you stand.

The review is free and private. Asking for it doesn’t commit you to anything.

Register your interest

Sources

  1. FDA Exactech joint device safety communicationFDA Exactech joint device safety communication · regulator
  2. FDA AcuMatch XLE recall recordZ-1165-2025FDA AcuMatch XLE recall recordZ-1165-2025 · regulator
  3. FDA What is a Medical Device Recall?FDA What is a Medical Device Recall? · regulator
  4. Exactech US Recall InformationExactech US Recall Information
  5. Exactech Recall Serial Number CheckerExactech Recall Serial Number Checker
  6. Exactech Hip FAQ current reimbursement noticeExactech Hip FAQ current reimbursement notice
  7. Garaufis MDL3044 Practice and Procedure Order1Garaufis MDL3044 Practice and Procedure Order1 · court
  8. Silverstein Exactech bankruptcy discovery letterSilverstein Exactech bankruptcy discovery letter · court
  9. USCourts Chapter11 Bankruptcy BasicsUSCourts Chapter11 Bankruptcy Basics · court
  10. ABA Model Rule1.5 FeesABA Model Rule1.5 Fees
  11. HHS your medical recordsHHS your medical records · regulator
  12. SDNY how long do I have to file?SDNY how long do I have to file? · court
  13. Exactech filed Chapter 11 in the US Bankruptcy Court for the District of Delaware (Oct 30, 2024), citing product-liability claims from ~2,600 patients over its recalled knee/hip/ankle implants; recalls and litigation had cost ~$20 million over the prior 12 months. Existing investors provided $85 million in funding and served as stalking-horse bidder for substantially all assets. The filing stayed MDL 3044 litigation against the company.medtechdive.com · Oct 30, 2024
  14. AAOS OrthoInfo: Revision total knee replacement
  15. Gausden et al., Bone & Joint Journal (2023): Optetrak knee survival
  16. Exactech Settlement Trust distribution procedures (July 2025 version)
  17. FDA recall record Z-0582-2024: Optetrak vacuum-bag recallFDA recall record Z-0582-2024: Optetrak vacuum-bag recall · regulator
  18. FDA recall record Z-2155-2024: Optetrak patella partsFDA recall record Z-2155-2024: Optetrak patella parts · regulator
  19. AAOS OrthoInfo: Infection after joint replacementAAOS OrthoInfo: Infection after joint replacement
  20. Shnaekel et al., Arthroplasty Today (2023): loose Logic and Truliant partsShnaekel et al., Arthroplasty Today (2023): loose Logic and Truliant parts · study
  21. Kahlenberg et al., Arthroplasty Today (2020): early GXL liner wearKahlenberg et al., Arthroplasty Today (2020): early GXL liner wear · study
  22. Bankr. D. Del., order confirming the Fifth Amended Plan, Doc. 1647 (Sept. 17, 2025)Bankr. D. Del., order confirming the Fifth Amended Plan, Doc. 1647 (Sept. 17, 2025) · court

Checked against 14 primary sources by People's Justice editors · Updated

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People's Justice research team · Updated Oct 5, 2026