Injury guide

Knee replacement revision

Updated Oct 6, 202623 sources

Revision surgery takes out some or all parts of a knee implant that failed and puts in new ones. Here are the records that matter and what the Exactech lawsuits claim.

What the public record says

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

U.S. Judicial Panel on Multidistrict Litigation · Summary of the claims (MDL No. 3044), not a ruling

“Plaintiffs in the actions before us allege that their knee or hip replacement devices (Optetrak and Truliant, and Connexion GXL, respectively) failed prematurely because of degradation of the device’s polyethylene component”

JPML transfer order, Exactech MDL No. 3044 (Oct. 7, 2022) (opens in a new tab) · Oct 7, 2022 · Checked Oct 6, 2026

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 knee replacements done at one hospital from 2010 to 2018; 369 later revisions were reviewed.
Finding:
In 209 of the 369 revisions, surgeons found worn plastic with joint-lining swelling, bone loss and loose parts. These failures came about five years after the first surgery, on average.
Main limitation
One hospital looking back at its records, with no comparison group in the abstract. Only the abstract was read.

Read the source: Mid-term survivorship of primary total knee arthroplasty with a specific implant (opens in a new tab) · Checked Oct 6, 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 Optetrak Logic and Truliant knee replacements in one practice.
Finding:
17 knees were redone because the thigh-bone part came loose, about six years after surgery on average. More than half of these patients had plain X-rays that did not show the loosening.
Main limitation
One practice looking back at records. The authors say counting only revisions may miss some loose implants.

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 6, 2026

The short answer

What is knee replacement revision, and why is it done?
It is a second surgery on a knee that already has an implant. The surgeon takes out some or all of the old parts and puts in new ones. It is done when the first implant fails. [1]
When should I talk to my doctor about knee replacement revision?
Call your doctor if your knee has new or worse pain or swelling, you can’t put weight on it, or it grinds or feels weak. FDA gives this advice to people with Exactech joints. Only you and your surgeon can decide whether a second surgery makes sense. [2]
How is knee replacement revision done, and how are problems treated?
First, doctors look for the cause. X-rays can show parts that are loose or out of place. Blood tests, and fluid drawn from the knee with a needle, check for infection. [1]
Which records matter after knee replacement revision?
Start with the operative report from each surgery. Federal rules for hospitals say the surgeon must write or dictate it right after surgery and sign it. It describes what the surgeon found and what was taken out. [3]

What rules a case out

Not covered by this case

  • This page is not medical advice. Only you and your surgeon can decide about surgery.
  • It does not cover hip replacement revision or how the Exactech bankruptcy handles claims.

What is knee replacement revision, and why is it done?

It is a second surgery on a knee that already has an implant. The surgeon takes out some or all of the old parts and puts in new ones. It is done when the first implant fails.

A failing knee may hurt, swell, feel stiff or feel like it gives way. Reasons include parts that come loose or wear down, infection, a knee that is not stable, and a broken bone near the implant.

Sometimes only one part is changed. MedlinePlus says a knee implant can be replaced again if it gets loose or wears out, but results are usually not as good as the first time.

When should I talk to my doctor about knee replacement revision?

Call your doctor if your knee has new or worse pain or swelling, you can’t put weight on it, or it grinds or feels weak. FDA gives this advice to people with Exactech joints. Only you and your surgeon can decide whether a second surgery makes sense.

FDA does not advise surgery to remove an Exactech implant that works well and causes no pain. A recall alone does not mean a device must come out. Companies often ask doctors to talk with patients about the risk of taking a device out compared with leaving it in.

Never have a device removed just for a lawsuit. Make the choice for your health, with your surgeon. Bring a list of your questions, and keep asking until the answers make sense.

How is knee replacement revision done, and how are problems treated?

First, doctors look for the cause. X-rays can show parts that are loose or out of place. Blood tests, and fluid drawn from the knee with a needle, check for infection.

In surgery, the doctor opens the old scar, sometimes making it longer. Worn or loose parts come out with care, to save as much bone as possible. Metal pieces can fill in where bone was lost.

If the knee is infected, the surgeon may wash it out and change only the plastic part. Other times the whole implant comes out first. A spacer with germ-fighting medicine stays in for some weeks before the new knee goes in.

Revision takes longer than the first surgery, and the risk of problems is higher. Risks include infection, blood clots and a broken bone during surgery. Most people do well over time, but some still have pain or stiffness.

Which records matter after knee replacement revision?

Start with the operative report from each surgery. Federal rules for hospitals say the surgeon must write or dictate it right after surgery and sign it. It describes what the surgeon found and what was taken out.

Ask for the implant record from your first knee surgery too. A device label carries a code called a UDI that names the exact model, and it can also show the batch. Exactech’s online lookup for knee and ankle implants asks for your device serial number.

Ask whether the parts taken out were kept, and where they went. FDA’s problem report form asks if a device can still be examined, or if it went back to the maker. In the Exactech cases, the court told the lawyers to work on a plan for keeping removed devices and tissue samples.

If tissue went to a lab, ask for the pathology report. It describes what the lab saw, both by eye and under a microscope.

You have a right to copies of your records, X-rays included. Our medical records request tool can help you write the letter.

What does research say about Exactech implants and revision?

FDA says many Exactech knee, ankle and hip parts were packed in bags that were missing one of the layers that keep out oxygen. It says some recalled devices are linked to a higher risk of a second surgery and bone loss from wear. That is not a finding about any one person’s joint.

FDA’s recall records say the knee inserts were packed in vacuum bags that lacked an extra oxygen barrier layer. The records also list Vantage ankle liners.

If you have an Exactech ankle: MedlinePlus lists loosening over time as a risk of any ankle replacement. When the federal cases were grouped in 2022, none were about the Vantage ankle. Ask your foot and ankle surgeon what your scans show.

A Hospital for Special Surgery study looked at 7,941 Optetrak knees. In 209 of 369 revisions, surgeons found worn plastic, bone loss and loose parts. These failures came about five years after the first surgery, on average.

A Nashville clinic found that 17 of 896 Optetrak Logic and Truliant knees were redone because the thigh-bone part came loose. More than half of these patients had plain X-rays that did not show it.

Studies like these describe groups of patients. They cannot show why one person’s implant failed. In the federal court records we read, we found no ruling on whether the packaging caused anyone’s harm.

Who brings Exactech knee and hip claims?

People with Exactech knee or hip implants who needed, or were told they need, another surgery brought these cases. They claim the plastic parts broke down too early. A lawyer can look at your records and tell you if you may have a claim.

In 2022 the federal cases were grouped before one judge in the Eastern District of New York. In November 2024, after Exactech filed for bankruptcy, the court paused them. The Exactech case page and its page on second surgeries list what to check and what to ask about claims now.

Can a family member get records after knee replacement revision?

Often, yes. Under HIPAA, a personal representative, someone with legal power to act for the patient, is treated like the patient when asking for records. A health care power of attorney is one example. State law decides who counts.

If the patient has died, the executor or administrator of the estate can get the records that the estate’s work needs. HIPAA keeps protecting a person’s health records for 50 years after death.

While the person is alive, a doctor may share details with a family member who helps with care, unless the person says no.

After a death, a doctor may also share what relates to their role with relatives or friends who helped with care or paid for it, unless the person had said not to.

When a patient has died, the wrongful death case page explains in general how those claims work.

Sources

  1. AAOS OrthoInfo: Revision total knee replacement
  2. FDA safety communication: Exactech joint devices with defective packaging
  3. eCFR: 42 CFR 482.51, hospital surgical services (operative reports)
  4. JPML transfer order, Exactech MDL No. 3044 (Oct. 7, 2022)
  5. MedlinePlus: Knee joint replacementMedlinePlus: Knee joint replacement · regulator
  6. FDA: What is a medical device recall?FDA: What is a medical device recall? · regulator
  7. MedlinePlus: Talking with your doctorMedlinePlus: Talking with your doctor · regulator
  8. AAOS OrthoInfo: Infection after joint replacementAAOS OrthoInfo: Infection after joint replacement
  9. FDA: UDI basicsFDA: UDI basics · regulator
  10. FDA: MedWatch Form 3500 (device problem report)FDA: MedWatch Form 3500 (device problem report) · regulator
  11. E.D.N.Y.: Exactech MDL Case Management Order No. 1 (Jan. 26, 2023)E.D.N.Y.: Exactech MDL Case Management Order No. 1 (Jan. 26, 2023) · court
  12. NCI: Pathology reportsNCI: Pathology reports · regulator
  13. HHS: Your right to access your health informationHHS: Your right to access your health information · regulator
  14. FDA recall Z-0019-2022: Optetrak knee insertsFDA recall Z-0019-2022: Optetrak knee inserts · regulator
  15. FDA recall Z-0024-2022: Vantage ankle linersFDA recall Z-0024-2022: Vantage ankle liners · regulator
  16. MedlinePlus: Ankle replacementMedlinePlus: Ankle replacement · regulator
  17. Gausden et al., Bone & Joint Journal (2023): Optetrak knee revisionsGausden et al., Bone & Joint Journal (2023): Optetrak knee revisions · study
  18. Shnaekel et al., Arthroplasty Today (2023): loose femoral partsShnaekel et al., Arthroplasty Today (2023): loose femoral parts · study
  19. E.D.N.Y.: Exactech MDL docket, order staying the cases (Nov. 1, 2024)E.D.N.Y.: Exactech MDL docket, order staying the cases (Nov. 1, 2024) · court
  20. HHS: Personal representatives under HIPAAHHS: Personal representatives under HIPAA · regulator
  21. eCFR: 45 CFR 164.502(g), personal representativeseCFR: 45 CFR 164.502(g), personal representatives · regulator
  22. HHS: Health information of deceased individualsHHS: Health information of deceased individuals · regulator
  23. eCFR: 45 CFR 164.510(b), sharing with family involved in careeCFR: 45 CFR 164.510(b), sharing with family involved in care · regulator

Checked against 23 primary sources by People's Justice editors · Updated

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