Why is my Exactech knee replacement causing pain years after surgery?

Why is my Exactech knee replacement causing pain years after surgery?

If your knee replacement has never felt right — or has started getting worse — you deserve a clear explanation of what may have gone wrong and why.
Exactech manufactured knee replacement implants used in thousands of surgeries across Australia. In 2022, the company recalled a large number of these devices after discovering a packaging defect that caused the plastic liner inside the implant to degrade faster than expected. Many patients had already lived with these implants for years — some for more than a decade — before the recall happened. If your knee replacement has been painful, unstable, or has required revision surgery, this article explains what the Exactech recall was about, what it means for your health, and what your options are.
What Should Happen: The Usual Process for a Knee Replacement Implant
STEP 1

Surgeon selects an implant with a sterile, intact polyethylene liner

STEP 2

Implant is fitted correctly and patient recovers with normal rehabilitation

STEP 3

Surgeon monitors the implant at regular follow-up appointments

STEP 4

Any signs of wear, loosening, or pain trigger imaging and review

STEP 5

Patient lives with a stable, functioning implant for 15–20 years

When a defective implant is used, or when early warning signs of degradation go unaddressed, patients may suffer years of unnecessary harm before the problem is identified.

Understanding the Exactech knee prosthesis: what it is and what normally happens

A knee replacement — also called total knee arthroplasty — is a surgical procedure where a surgeon removes the damaged surfaces of the knee joint and replaces them with artificial components. Most knee replacements involve three parts: a metal component fixed to the end of the thigh bone, a metal component fixed to the top of the shin bone, and a plastic spacer that sits between them.

That plastic spacer is called a polyethylene liner. Its job is to act as a smooth, durable cushion between the two metal parts. Without it, metal would grind against metal. The liner absorbs impact, allows movement, and keeps the joint stable.

What Exactech made and who used it

Exactech is an American orthopaedic device company. For many years, surgeons in Australia and around the world used Exactech knee implants — including the Optetrak and Truliant systems — in knee replacement surgeries. These devices were approved for use and considered safe at the time of implantation.

A well-functioning knee replacement should last 15 to 20 years. Patients typically experience some discomfort during recovery, but most return to normal daily activities within a few months. After that, the implant should feel stable and relatively pain-free.

The recall: In 2022, Exactech recalled hundreds of thousands of knee, hip, and ankle implants globally after discovering that the packaging used for the polyethylene liners was defective.

The defect: The packaging lacked a proper oxygen barrier. Over time, oxygen entered the packaging and caused the plastic liner to oxidise — meaning it broke down chemically before it was even implanted, or degraded much faster than expected after implantation.

The scale: Exactech estimates the recall affected approximately 147,000 knee implant components worldwide. Many Australian patients received affected devices.

The timeline: Some affected packaging dates back to 2004, meaning patients may have lived with a degraded implant for nearly two decades before the recall was announced.

For more general information about joint replacement surgery and what to expect, Healthdirect Australia provides reliable, plain-language health information.

When things start to go wrong — warning signs after a knee replacement

Some discomfort after knee replacement surgery is normal. Swelling, stiffness, and mild pain in the first weeks and months are expected parts of recovery. But certain symptoms — especially those that appear after the initial recovery period, or that worsen over time — deserve careful attention.

Warning signs that should prompt a review of your knee implant:

• Pain that returns or worsens after an initial period of improvement

• A feeling of instability, looseness, or “giving way” in the knee

• Swelling that does not settle or that comes back without a clear cause

• A grinding, clicking, or catching sensation inside the joint

• Reduced range of motion compared to what you had after recovery

• Difficulty walking, climbing stairs, or bearing weight on the leg

• Redness or warmth around the knee joint without signs of infection

• Your surgeon telling you the implant has worn down or loosened earlier than expected

With Exactech implants specifically, the degraded polyethylene liner tends to wear down faster than a normal liner would. As it wears, tiny plastic particles shed into the joint. The body treats these particles as foreign material and mounts an inflammatory response. Over time, this inflammation can destroy the surrounding bone — a process called osteolysis.

Osteolysis means bone loss. Once bone loss begins, the implant loses its stable foundation. This leads to loosening, pain, and ultimately the need for revision surgery — a second operation to replace the failed implant.

A common pattern — where care can break down

The Exactech recall created a specific set of circumstances where patients could fall through the cracks. Understanding these patterns helps explain why some people suffered harm for years without knowing why.

Failure to notify patients after the recall

When Exactech announced the recall in 2022, surgeons and hospitals had an obligation to identify which of their patients had received affected implants and to notify those patients promptly. Some patients received timely notification and were brought in for review. Others heard nothing — sometimes for months, sometimes not at all.

A patient who was not told about the recall could not make an informed decision about whether to seek further imaging or monitoring. Delayed notification meant delayed diagnosis of implant failure.

Dismissing symptoms as normal wear

Some patients reported pain and instability to their surgeon before the recall was announced. In a number of cases, surgeons attributed these symptoms to normal ageing of the implant or to the patient’s own activity levels. Without knowing about the packaging defect, clinicians sometimes missed the true cause.

After the recall, however, a different standard applied. A surgeon who continued to dismiss symptoms without investigating the implant’s condition — particularly in a patient with a known recalled device — may not have met the expected standard of care.

Delayed referral for imaging or revision

Even when a surgeon identified that a patient had a recalled implant, some patients waited a long time before receiving imaging to assess the extent of liner degradation or bone loss. Others waited even longer before revision surgery was offered or performed.

Delays in this context matter. Bone loss from osteolysis is not always reversible. The longer a degraded implant remains in place, the more bone the body destroys — and the more complex and risky the eventual revision surgery becomes.

Inadequate pre-operative information

Some patients were not told, before their original surgery, that the specific implant being used carried any particular risks. While no surgeon could have predicted the packaging defect years in advance, the broader question of informed consent — whether patients understood the risks of the device they were receiving — remains relevant in some cases.

The Australian Commission on Safety and Quality in Health Care sets national standards for how hospitals and clinicians should manage patient safety, including device recalls and adverse event notifications.

What should have happened after the recall

Surgeon identifies all patients with affected Exactech implants

Patient receives written notification promptly

Imaging is arranged to assess liner condition and bone integrity

Surgeon discusses revision options and timing with the patient

Patient makes an informed decision with full information

What sometimes happened instead

Patient was not notified or was notified very late

Symptoms were dismissed as normal ageing of the implant

Imaging was delayed or not ordered at all

Revision surgery was postponed, allowing bone loss to worsen

Patient was not told the implant was subject to a recall

Why this matters legally

Every doctor, surgeon, and hospital in Australia owes their patients a duty of care. That means a legal obligation to provide treatment that meets the standard a competent clinician in the same field would reasonably provide. When a clinician falls below that standard and a patient suffers harm as a result, the law may treat that as medical negligence — a legal term meaning a failure of care that caused measurable harm.

Not every bad outcome from a knee replacement is negligence. Implants can fail for reasons unrelated to anyone’s conduct. Revision surgery is sometimes necessary even when everything was done correctly. The question the law asks is not “did something go wrong?” but “did the clinician do what a reasonable clinician would have done in the same situation?”

With Exactech implants, the legal picture has two distinct layers. First, there is the question of the manufacturer’s responsibility — Exactech produced and sold a defective product. Second, there is the question of what the treating surgeon and hospital did once the recall was announced. Both layers can be relevant to a patient’s situation.

For a broader overview of how medical negligence works in Australia, Reframe Legal — Medical Negligence explains the key concepts in plain language.

When Does a Care Failure Become Legal Negligence? — The Three Elements
1. Duty of Care
The surgeon and hospital owed you a duty to provide competent care — including monitoring your Exactech implant and acting on the recall

2. Breach
The care fell below the standard a competent orthopaedic surgeon would have met — for example, by failing to notify you or delaying investigation of your symptoms

3. Causation
The failure caused harm — such as bone loss, a more complex revision surgery, or prolonged pain — that earlier action would have prevented or reduced

NOT necessarily negligence

A knee replacement that required revision surgery after 15 years of normal use, where the implant was not part of the recall and the surgeon monitored the patient appropriately throughout

MAY BE negligence

A surgeon who knew a patient had a recalled Exactech implant, received reports of pain and instability, and delayed imaging or revision surgery — allowing significant bone loss to develop

This is a general educational framework only. Each case is assessed on its individual facts.

When an Exactech knee prosthesis failure may amount to medical negligence

The NSW Civil Liability Act 2002 is the main law governing personal injury claims in New South Wales. It sets out the rules for how courts assess whether a clinician’s conduct fell below an acceptable standard, and how they calculate the harm a patient suffered as a result.

Several specific scenarios may give rise to a legal claim in the context of an Exactech knee implant failure.

If your surgeon did not notify you of the recall. After Exactech announced the recall, surgeons had an obligation to identify affected patients and inform them. A surgeon who failed to do this — and whose patient went on to suffer additional bone loss or a more complex revision — may have fallen below the expected standard.

If your symptoms were dismissed after the recall was known. A patient who reported pain, instability, or reduced function after the recall announcement deserved a thorough investigation. A surgeon who attributed those symptoms to normal wear without checking whether the implant was affected may not have met the standard a competent orthopaedic surgeon would have applied.

If revision surgery was delayed without good clinical reason. Once imaging confirmed liner degradation or bone loss, a surgeon who delayed revision surgery without a clear clinical justification — and whose patient suffered worsening bone destruction during that delay — may have caused harm that earlier action would have prevented.

If you were not told the implant was subject to a recall before a decision was made. Patients have a right to make informed decisions about their treatment. A surgeon who knew about the recall but did not disclose it to a patient considering their options may have failed to meet the informed consent standard.

When harm becomes long-term or permanent

For many Exactech patients, the harm did not stop at pain and inconvenience. The degradation of the polyethylene liner set off a chain of physical consequences that, in some cases, became permanent.

Physical consequences

Osteolysis — the bone loss caused by the body’s reaction to plastic particles — can be severe. In advanced cases, surgeons find large cavities in the bone where healthy tissue once existed. Revision surgery in these patients is far more complex than a straightforward implant replacement. Surgeons may need to use bone grafts or specialised implants to reconstruct the joint. Recovery takes longer, and the outcome is less predictable.

Some patients experience permanent reduction in knee function even after successful revision surgery. Others require multiple revision procedures. Each additional surgery carries its own risks — infection, blood clots, nerve damage, and anaesthetic complications.

Psychological consequences

Living with chronic pain and reduced mobility takes a significant psychological toll. Many Exactech patients describe years of being told their pain was normal, only to discover later that a defective device was the cause. That experience — of not being believed, of having concerns dismissed — can contribute to anxiety, depression, and a loss of trust in medical care.

Financial consequences

Revision surgery is expensive. For patients in the private system, out-of-pocket costs can be substantial. Many patients also lose income during recovery — particularly those in physically demanding jobs. Some cannot return to their previous work at all. The cumulative financial impact of a failed knee replacement, across multiple surgeries and extended recovery periods, can run into the hundreds of thousands of dollars.

  • 1
    Original surgeryPatient receives an Exactech knee implant. The packaging defect means the liner may already be degrading.
  • 2
    Early symptomsPatient reports pain or instability. Clinician attributes symptoms to normal recovery or general wear.
  • 3
    Recall announced (2022)Exactech announces the recall. Some patients are notified promptly. Others are not told for months.
  • 4
    Imaging and assessmentPatients who receive timely imaging discover the extent of liner wear and bone loss. Those who are not assessed continue to deteriorate.
  • 5
    Revision surgeryMany patients require revision surgery. The complexity — and the outcome — depends heavily on how much bone loss occurred before the problem was addressed.

What compensation can cover in Exactech knee prosthesis cases

In NSW, a successful medical negligence claim can cover several categories of loss. These include pain and suffering, loss of enjoyment of life, past and future medical expenses, past and future lost income, and the cost of care and assistance — including help at home during recovery.

In Exactech cases specifically, compensation may also address the cost of revision surgery, rehabilitation, and any ongoing treatment required as a result of the implant failure. Where bone loss has caused permanent disability, courts assess the long-term impact on the patient’s capacity to work and live independently.

Level of harm Typical compensation range
Moderate injury $50,000–$150,000
Serious injury $150,000–$500,000
Severe / life-changing injury $500,000+

Each case is assessed on its own facts. These figures are general ranges only. The amount recoverable depends on the severity of the harm, the patient’s age and circumstances, and the strength of the evidence connecting the failure to the outcome.

Time limits apply in NSW. Generally, a person has three years from the date they knew — or ought reasonably to have known — that they had a potential claim. For Exactech patients, this clock may have started running from the date of the recall announcement, or from the date a surgeon told them their implant had failed. Getting advice sooner rather than later preserves your options.

Bringing it together — do the pieces fit?

If you have an Exactech knee implant and you have experienced pain, instability, or revision surgery, it is worth asking yourself a series of honest questions about what happened and when.

Questions to ask yourself
These are not legal questions. They are prompts to help you think clearly about what happened.
?
Did your surgeon notify you about the Exactech recall in 2022, and if so, how quickly?

?
Did you report pain or instability before the recall, and were those symptoms investigated or dismissed?

?
Did your surgeon arrange imaging to check the condition of the liner and surrounding bone after the recall?

?
Did you require revision surgery, and was the bone loss at that point more extensive than your surgeon expected?

?
Has your knee function after revision surgery been significantly worse than what you were told to expect?

If several of these resonate with your experience, the circumstances may be worth examining more carefully.

The connection between a care failure and a legal claim is not always obvious from the inside. A lawyer with experience in medical device cases can review your records, identify what the treating clinician knew and when, and assess whether the response to the recall met the expected standard.

For a detailed explanation of how the claims process works in NSW, Reframe Legal — How Medical Negligence Claims Work in NSW walks through each stage clearly.

You don’t need certainty to understand your position

Many people who experienced problems with an Exactech knee implant spent years wondering whether their pain was normal. Some were told it was. Some blamed themselves — their weight, their activity level, their age. The recall changed that picture entirely. It confirmed that the device itself was defective, and that the suffering many patients experienced was not inevitable.

But knowing the device was defective is not the same as knowing whether your specific clinician did everything they should have done. That question requires a careful look at your medical records, the timing of your symptoms, what your surgeon knew, and what actions they took or did not take.

You do not need to arrive at a legal conclusion on your own. Uncertainty is normal. What matters is whether the facts, once examined carefully, reveal a gap between what happened and what should have happened.

If your situation involved questions about what you were told before surgery — about the implant, its risks, or your options — the law around informed consent may also be relevant. Reframe Legal — Informed Consent and Medical Negligence explains how that area of law works.

Patients who wish to make a formal complaint about a treating clinician — separate from any legal claim — can do so through AHPRA — Australian Health Practitioner Regulation Agency, which regulates registered health practitioners across Australia.

About the lawyer behind this article

Dr Rosemary Listing — Medical Negligence Lawyer

Dr Rosemary Listing is an Australian lawyer with a PhD in medical negligence. Her academic and legal work focuses on the gap between what patients are owed and what they actually receive — particularly in cases involving defective medical devices, surgical errors, and failures in post-operative monitoring.

Rosemary has worked with clients whose Exactech knee implants failed, and whose surgeons did not respond to the recall in the way a competent clinician should have. She understands the specific clinical pathway these cases follow — from the original implantation, through the recall notification process, to the imaging and revision decisions that followed.

In her experience, the harm in these cases rarely comes from the surgery itself. It comes from what happened — or did not happen — after the recall was announced. Delays in notification, dismissed symptoms, and postponed revision surgery are the points where a patient’s outcome diverges from what it should have been.

Clients who approach Rosemary are not looking to blame anyone. Most simply want to understand whether what happened to them was acceptable, and whether the years of pain and the complexity of their revision surgery were avoidable. Her role is to examine the facts carefully and give an honest assessment of whether the standard of care was met.

Rosemary practises in New South Wales and accepts matters from patients across the state. Her focus is on giving people the information they need to make a clear-headed decision about their situation — without pressure and without false certainty.

This article is general legal information only. It does not constitute legal advice. Each person’s circumstances are different. The law discussed applies to New South Wales, Australia. Time limits apply to legal claims.

Contact Dr Rosemary Listing At Peter Evans & Associates

Related articles

Contact Dr Rosemary Listing At Peter Evans & Associates

Whether it is a medical injury, a contract dispute, or a workplace issue, uncertainty can be exhausting. You should not have to guess where you stand. You need clarity, fast.

Along with her team at Peter Evans & Associates, she will help you understand:

Contact Peter Evans & Associates

Send an enquiry

Prefer to reach out directly? Complete the form below, and we’ll respond as soon as we can.

All enquiries go to Dr Rosemary Listing at Peter Evans & Associates.