Knee Implant Failure

A knee replacement is made of several parts, and a problem with one, such as a plastic insert that wears out early, can lead to pain, bone loss and revision surgery. Exactech recalled knee devices packed in bags missing an oxygen barrier, which can let the plastic degrade. Not every knee that fails is defective. A knee implant lawyer looks at which part failed and why.

The parts of a knee implant

A knee replacement usually has a metal piece capping the end of the thigh bone (the femoral component), a metal tray on the shin bone (the tibial component), a plastic insert between them and sometimes a plastic button on the kneecap. The plastic insert is a bearing surface and is often where wear shows up. Each part has its own label and lot number.

The Exactech knee recall

Exactech recalled knee and ankle devices packed in bags that were missing one of their oxygen barrier layers. On Feb. 7, 2022, it expanded the recall to all Optetrak, Logic and Truliant knee replacements and Vantage ankle replacements packed in the defective bags, regardless of label or shelf life. Exactech said about 80% of its knee and ankle devices made since 2004 were packed in the defective bags1.

Oxygen reaching the plastic before implantation can cause oxidation over time. The FDA lists the risks as early and excessive wear, component fracture, device failure, new or worsening pain, bone loss, swelling and revision surgery. The affected devices were made from 2004 to August 2021 and may have been implanted through Feb. 7, 2022. The FDA classified the knee and ankle recall as Class II on Oct. 4, 2021, and Exactech issued an updated correction notice on April 7, 20221.

Exactech knee recall dates

1. 2004 to Aug. 2021

   Affected devices manufactured1.

2. Oct. 4, 2021

   FDA classifies the knee and ankle recall as Class II.

3. Feb. 7, 2022

   Recall expanded to all Optetrak, Logic and Truliant knees and Vantage ankles in defective bags.

4. Apr. 7, 2022

   Updated Urgent Medical Device Correction notice.

5. Mar. 23, 2023

   FDA safety communication reminding patients and providers.

Exactech has an online database to check whether a knee or ankle implant is part of the recall. The FDA does not recommend surgery to remove a well-functioning device in someone without new or worsening symptoms1.

Other reasons knees fail

Knee implants can loosen, wear, become unstable or break, and the reason isn't always a defect. Infection, the alignment of the parts, bone quality, injury and activity level all affect how a knee does. Pain alone doesn't show a defect. A review looks at imaging and, if there was a revision, what the surgeon found and why the parts were replaced.

• Polyethylene wear or cracking of the insert
• Loosening of the femoral or tibial component
• Bone loss around the implant
• Instability or fracture of a component
• Infection, which is a separate cause from a device defect

Several Exactech-related concerns also affect hips; see hip implant failure.

Knee implant litigation

Federal Exactech cases are coordinated in MDL No. 3044, In re Exactech Polyethylene Orthopedic Products Liability Litigation, before Judge Nicholas G. Garaufis in the Eastern District of New York. The JPML's Nov. 2, 2026 report lists 1,838 actions pending2. An MDL coordinates individual cases and is not a class action or a settlement3. If a manufacturer is in bankruptcy, claims may need to go through a separate court process with its own deadlines, so current court records have to be checked before any claim is described.

Who may have a knee implant claim

• A recalled insert or component confirmed by lot or serial number
• Revision surgery for wear, loosening or bone loss
• Imaging showing early wear or failure
• Lasting limits on walking, stairs or work after failure

Who may be responsible

An investigation may look at the maker of the specific component, based on the recall, the packaging history and revision findings. Surgical alignment and care are reviewed separately.

Filing deadlines for knee implant lawsuits

Deadlines depend on your state and on when you learned of the failure and its possible cause. Examples:

• Arizona: generally two years for personal injury and wrongful death4.
• California: two years for injury to or death of a person caused by another's wrongful act or neglect5.
• New York: three years for personal injury6, with a separate rule that runs from discovery for injuries caused by the latent effects of exposure to a substance in the body7.
• Texas: two years for personal injury and wrongful death8, and most product liability claims must be brought within 15 years of the product's sale9.

When the clock starts can depend on when a person knew, or should have known, about the injury and its possible cause. Rules for minors, wrongful death and claims against public hospitals can differ. A device that was part of an earlier settlement can raise its own questions. Ask a medical device attorney to check the rules for your state early, before records are lost.

Tell Us Your Story →

Records that help a knee implant review

Records worth gathering

Implant record

• Labels for the femoral, tibial and insert components
• Lot and serial numbers
• Recall database result

Failure

• X-rays and other imaging
• Revision operative report
• Cultures or pathology, if taken

Impact

• Physical therapy records
• Work or mobility limits

What happens after you contact CBW Law

How a review works

1. Tell us what happened

   Share what you remember about the knee implant, the problem and the treatment that followed. You do not need every record first.

2. We identify the device

   We work to confirm the maker, model and lot or serial number, and whether any recall or safety notice covers it.

3. We gather records

   With your permission, we request operative reports, imaging, device data and other records from your providers.

4. We explain what we see

   We tell you what the records show, what questions remain and what options may be open, including deadlines.

Knee pain after a replacement is common and has many causes. A claim depends on which part failed and what the records show about why.

Plain English

Medical, Health & Insurance

Terms you may see in a knee implant case.

Implant parts

Femoral component

The metal cap on the end of the thigh bone.

Tibial component

The metal tray on the top of the shin bone.

Polyethylene insert

The plastic bearing between the metal parts; the part affected by oxidation in the Exactech recall1.

Problems

Aseptic loosening

An implant coming loose without infection.

Osteolysis

Bone loss around an implant, often linked to wear particles.

Treatment

Revision

Surgery to replace some or all of a knee implant.

Questions

Knee implant lawsuit questions

Short answers to the questions people ask first.

Which part of my knee failed?

The revision report and imaging usually say. Bring them to your review.

Was my insert part of the Exactech recall?

Exactech has an online lookup for knee and ankle devices. A knee implant lawyer can help check the lot or serial number.

Does persistent pain prove my knee implant is defective?

No. Pain has many causes. A review looks for documented wear, loosening or failure.

Should I have my Exactech knee removed?

The FDA does not recommend removing a well-functioning device in someone without symptoms. Talk to your surgeon.

How long should a knee replacement last?

It varies by person and implant. There's no fixed lifespan that proves a defect.

Is there an Exactech class action?

Federal Exactech cases are coordinated in MDL No. 3044, which handles individual cases together.

What if Exactech is in a bankruptcy process?

Claims may need to follow a separate court process with its own deadlines. A knee implant attorney has to check current court records.

How long do I have to file a knee implant lawsuit?

It depends on your state and on when you learned about the failure and its possible cause.

What records matter most?

Component labels, imaging and the revision report.

What does it cost to contact CBW Law?

Telling us your story costs nothing, and contacting us does not create an attorney-client relationship.

Tell Us Your Story

If your knee implant failed early, a knee implant attorney can review what happened.

Tell us what happened. CBW Law will review your information and explain what we see. Submitting information does not establish an attorney-client relationship or guarantee representation.

Tell Us Your Story →Call (800) 476-2416

This page is general information about knee implant failure. It is not legal or medical advice and does not create an attorney-client relationship. A revision surgery, a recall or ongoing pain does not, by itself, establish that an implant was defective or that anyone is legally responsible. Talk to your surgeon before any decision about your implant. Laws and deadlines differ by state, and no outcome can be promised.