Did your Exactech knee replacement start failing — and did anyone tell you the implant itself might be the problem?
You had the surgery. You did the rehabilitation. You waited through the months of recovery that every surgeon told you were normal. And then the pain came back — or it never really left — and you started wondering whether something had gone wrong.
For thousands of Australians who received an Exactech knee prosthesis, that question now has a documented answer. In 2022, Exactech — the American manufacturer — recalled hundreds of thousands of knee, hip, and ankle implants worldwide after confirming that a packaging defect had allowed oxygen to degrade the polyethylene components inside the device.1 Polyethylene is the plastic insert that sits between the metal parts of a knee replacement and absorbs the load of every step you take. When it degrades prematurely, the implant fails — and the person carrying it pays the price.
The Therapeutic Goods Administration (TGA) — Australia’s medical device regulator — issued formal recall notices covering affected Exactech knee systems supplied in Australia.2 Many patients were not told promptly. Some are still waiting to understand what this means for them.
This article is written for people who received an Exactech knee implant and are now living with the consequences — whether that means ongoing pain, a revision surgery already completed, or a revision surgery still ahead. By the end, you will understand who was responsible for what, what the law says about defective medical devices, and what the harm you have experienced may be worth examining properly.
What you were entitled to — and may not have received
Every person who receives a medical implant is entitled to a device that meets the standard it was supplied to meet. That is not a high bar — it is the baseline. A knee prosthesis is not experimental technology. Surgeons, hospitals, and manufacturers all operate within a framework that requires the device to perform as represented, to be free from manufacturing defects, and to be supplied in packaging that preserves its integrity.3
Beyond the device itself, you were entitled to be told — promptly and clearly — when a recall affected your implant. Australian law places obligations on both the manufacturer and the treating clinician to notify patients when a device they carry has been recalled.4 Notification is not optional. It is not contingent on whether the clinician thinks you are symptomatic. The obligation to tell you exists the moment the recall is confirmed.
What it requires: When a medical device is subject to a recall, the sponsor (Australian distributor) and relevant healthcare providers must take all reasonable steps to identify affected patients and notify them of the recall action, the associated risk, and the recommended clinical response — including follow-up assessment.
Why this matters: If you were not told about the Exactech recall, or were told months after the recall was issued, the clinician or institution responsible for your ongoing care may have failed a specific, documented obligation — not just a general duty to keep you informed.
~147,000+
Multiple product lines
Significantly elevated vs standard revision rates
~6,000 per year
She had her knee replacement at sixty-two and spent eight months doing everything right — the physiotherapy, the walking, the careful return to activity. By the second year, the knee ached in a way that felt different from the surgical pain she had expected. Her surgeon told her that some patients simply took longer to settle. By the third year, she could not walk to the end of her street without stopping. A letter about the Exactech recall arrived — not from her surgeon, but forwarded by her GP — more than eighteen months after the recall had been issued. She had been living inside a failure that had a name, and no one had told her.
Where it goes wrong — the specific failure patterns
The packaging defect that degraded the implant before it was ever used
He was told his knee replacement was one of the best available — a premium implant from a reputable manufacturer. What no one told him was that the polyethylene insert inside the device had been stored in packaging that allowed oxygen to penetrate over time, accelerating the breakdown of the plastic before the implant was ever placed in his body. The device that went into his knee was already compromised. Within three years, the insert had worn in ways that a properly manufactured implant would not have shown for a decade or more.
The core failure in the Exactech recall was a manufacturing and quality control failure. Exactech used vacuum-sealed packaging for its polyethylene components — but a significant proportion of devices were packaged in bags that lacked a proper oxygen barrier, or were sealed incorrectly.6 Oxygen exposure causes oxidative degradation of polyethylene — a process that weakens the material, accelerates wear, and causes the implant to fail earlier than it should.
This defect was not visible on the outside of the packaging. Surgeons could not detect it by inspection. Hospitals could not identify it from the device label. The failure was internal — and Exactech knew, or should have known, that its packaging process carried this risk. Internal quality data available to the company indicated elevated wear rates in affected devices before the recall was formally issued.7
Australian law holds manufacturers responsible for defective goods that cause harm — regardless of whether the defect was intentional.8 The question is not whether Exactech meant to supply a defective device. The question is whether the device was defective, and whether that defect caused harm. For patients whose implants have shown premature wear, instability, or required revision surgery, both answers are likely yes.
The failure to notify patients promptly after the recall
Exactech issued its voluntary recall in February 2022. The TGA published recall notices for affected knee systems in Australia in the months that followed. Despite this, many Australian patients did not receive direct notification from their surgeon or hospital for many months — and some have still not been formally contacted.
The obligation to notify sits with multiple parties. Exactech’s Australian distributor held responsibility for notifying hospitals and surgical practices that had used the affected devices. Surgeons who implanted the devices held responsibility for identifying their patients and contacting them. Hospitals that maintained implant registers held responsibility for cross-referencing their records against the recall list.
Where any of these parties failed to act promptly, patients continued living with a device they did not know was recalled — unable to seek assessment, unable to make informed decisions about their care, and unable to take steps that might have reduced their harm.
The dismissal of symptoms that were, in fact, implant failure
Every time she went back to the clinic with pain, the answer was the same: this is normal, give it more time, some patients take longer. Her X-rays were reviewed and declared satisfactory. No one ordered the specific imaging that would have shown polyethylene wear. No one asked whether her implant was on the recall list. By the time a different surgeon — one she saw privately after moving interstate — identified the extent of the degradation, the bone around the implant had begun to suffer damage from the wear particles the failing insert had shed. The revision surgery she needed was now significantly more complex than it would have been twelve months earlier.
Premature polyethylene wear produces symptoms — pain, instability, swelling, a grinding or clicking sensation — that can be mistaken for normal post-surgical variation or for conditions unrelated to the implant. Clinicians who were not alert to the recall, or who did not check whether a patient’s device was affected, dismissed these symptoms as expected recovery variation.
The standard of care required clinicians, from the point of the recall, to actively consider implant failure as a differential diagnosis in any patient presenting with knee pain or instability following an Exactech implant. Failure to do so — and failure to order appropriate imaging, including CT or MRI where indicated — meant that implant degradation continued undetected, causing additional harm that earlier intervention would have prevented.
What happened: A plaintiff suffered harm from a product that failed to meet the standard of safety a person was entitled to expect. The manufacturer argued the defect was not foreseeable at the point of supply.
What the court found: Australian consumer law imposes liability on manufacturers for goods with safety defects regardless of fault — the question is whether the goods were as safe as persons generally are entitled to expect, not whether the manufacturer acted carelessly.
Why this matters: If your Exactech implant degraded prematurely because of a packaging defect, you do not need to prove that Exactech was reckless — only that the device was not as safe as you were entitled to expect.
For further information on national patient safety standards, the Australian Commission on Safety and Quality in Health Care publishes guidance on implant registries and recall obligations for healthcare providers.
What your own situation might mean
If you received an Exactech knee implant and have experienced pain, instability, swelling, or reduced mobility that your treating clinician attributed to normal recovery — and if your device was later confirmed as part of the recall — the failure to investigate implant degradation as a cause of your symptoms may have extended your harm unnecessarily.
If you were not notified of the recall within a reasonable time after it was issued, and you continued to suffer harm during that period, the delay in notification is itself a failure — separate from the original device defect. Both failures may be relevant to your legal position.
If you have already undergone revision surgery to replace the failed implant, the harm you experienced is documented. Revision surgery is significantly more complex than primary knee replacement — it carries higher risks, longer recovery, and often produces a less complete functional outcome than the original surgery would have if the device had performed correctly.
If you have not yet had revision surgery but have been told you need one, the harm is ongoing. Every week of living with a failing implant — the pain, the restricted movement, the uncertainty — is part of the harm the defect caused.
The legal picture — briefly
Multiple parties carry legal responsibility in Exactech implant cases. Exactech Inc. and its Australian distributor bear primary responsibility as the manufacturer and supplier of a defective device.9 Australian consumer law imposes strict liability on manufacturers for goods with safety defects — meaning the defect itself, and the harm it caused, is what matters, not whether the manufacturer intended it.10
Treating surgeons and hospitals carry a separate obligation — to notify patients promptly once a recall is confirmed, and to investigate implant failure as a cause of symptoms in any patient who presents with pain or instability following an affected device. Where a clinician failed to do either, that failure may give rise to a separate claim in negligence, independent of the product liability claim against the manufacturer.
The distinction that matters here is this: a bad outcome from a knee replacement is not automatically a legal claim. Knee replacements carry genuine risks — infection, blood clots, stiffness — that can occur even with perfect care and a perfectly functioning device. What makes the Exactech situation different is that the harm was caused by a documented defect in the device itself, and by documented failures in the notification and monitoring obligations that followed the recall.
For a broader overview of how these claims are assessed, see Reframe Legal — Medical Negligence.
A knee replacement that required revision surgery due to infection, blood clot, or mechanical loosening unrelated to polyethylene degradation — complications that occur within accepted clinical risk even with a properly manufactured device and appropriate care.
A knee replacement that failed within five years due to premature polyethylene wear in a device confirmed as part of the Exactech recall — particularly where the patient was not notified promptly, symptoms were dismissed without imaging, and revision surgery was required.
General educational framework only. Every case depends on its own facts.
The harm that follows
The harm from a failed Exactech implant does not end with the device failure. It accumulates — physically, psychologically, and financially — in ways that compound over time and that a legal claim must account for in full.
Physically, premature polyethylene degradation produces wear particles — microscopic fragments of plastic that shed into the joint space. These particles trigger an inflammatory response called osteolysis — the progressive destruction of the bone surrounding the implant. Osteolysis makes revision surgery more complex and its outcome less certain. A patient who received timely notification and early intervention faces a different surgical challenge than one whose bone loss was allowed to advance for an additional year or two.
Psychologically, the experience of living with a failing implant — particularly one that clinicians repeatedly told you was functioning normally — causes a specific kind of harm. The person doubts their own perception of pain. They delay seeking further help. They lose confidence in the medical system that was supposed to help them. Many people who have been through this describe a period of profound uncertainty that affected their sleep, their relationships, and their sense of their own body.
Financially, the costs accumulate quickly. Revision surgery in Australia carries significant out-of-pocket costs for privately insured patients, and waiting times in the public system mean that many patients wait in pain for extended periods. Lost income during recovery — which for revision surgery is typically longer and more difficult than the original procedure — adds to the burden. Ongoing physiotherapy, pain management, and mobility aids extend the financial impact further.
What compensation covers
Australian law allows compensation for the full range of harm caused by a defective medical device or a failure of clinical care. The categories are broad — and in Exactech cases, many of them apply simultaneously.
Pain and suffering damages — compensation for the physical pain and psychological distress caused by the implant failure and its consequences — are available where the harm meets the threshold required under the law in your state or territory.11 That threshold varies between jurisdictions, and the specific rules that apply to your situation depend on where you live and where the harm occurred.
The time limit for bringing a claim is generally three years from the date you knew — or ought reasonably to have known — that you had suffered harm as a result of a defective product or a failure of care.12 For many Exactech patients, that clock did not start running until they received recall notification or received a diagnosis of implant failure — not from the date of the original surgery. This is the discovery rule, and it matters: do not assume you have run out of time without taking advice.
| Severity of harm | Indicative range (Australia) | What this covers |
|---|---|---|
| Moderate injury with recovery | $50,000–$150,000 | Treatment costs, time off work, pain and disruption during recovery |
| Serious injury with lasting effects | $150,000–$500,000 | Permanent impairment, ongoing treatment, ongoing care needs |
| Severe or life-changing injury | $500,000–$2,000,000+ | Catastrophic loss of function, lifetime care, lost earning capacity |
General reference ranges only. Every case turns on its own evidence — medical records, expert clinical opinion, and financial reports that quantify actual loss.
For a detailed explanation of how the claims process works, see Reframe Legal — How Medical Negligence Claims Work in NSW.
Was what happened to you avoidable?
You may have spent months — or years — wondering whether the pain you were experiencing was something you were imagining, or something you simply had to accept. The answer, for many people who received an Exactech knee implant, is that it was neither.
The records will tell a clearer story than memory alone. The implant records, the surgical notes, the post-operative clinic entries, the imaging reports — these documents establish what the clinician knew, when they knew it, and what they did with that knowledge. In Exactech cases, the recall documentation adds another layer: it establishes what every clinician responsible for your care was required to know from the moment the recall was confirmed. Objective evidence, not recollection, is what a proper examination of your situation rests on.
Many people wait a long time before looking into this. The waiting is understandable — the experience of being told repeatedly that your pain is normal leaves a residue of self-doubt that takes time to work through. But the time limits that apply to these claims are real, and the discovery rule that protects many patients has limits of its own. If you have been carrying this question, the time to examine it properly is now — not because urgency should replace care, but because the evidence that answers the question is best examined while it is complete.
If you were not told about the recall before your surgery or before your symptoms worsened, the question of what you were entitled to know is directly relevant to your legal position. See Reframe Legal — Informed Consent and Medical Negligence for more on what Australian law requires clinicians to tell you.
The AHPRA — Australian Health Practitioner Regulation Agency also provides information about the obligations of registered health practitioners, including orthopaedic surgeons, in relation to patient notification and recall management.
About Dr Rosemary Listing
Dr Rosemary Listing holds both legal and medical qualifications, and practises exclusively in medical negligence and defective medical device claims across Australia. Her doctoral research examined the intersection of clinical standards and legal accountability in complex harm cases, with a particular focus on systemic failures involving multiple responsible parties.
Exactech implant cases sit at a difficult intersection. The harm is real and documented — a global recall confirms that. But the legal picture involves multiple parties, multiple obligations, and a harm trajectory that often spans years. Understanding what went wrong requires reading the clinical record through both a medical and a legal lens simultaneously: knowing what the imaging should have shown, what the recall notification required, and what the law says about each party’s responsibility at each point in time.
The people who seek a proper examination of their records are rarely looking to blame anyone. Most have spent a long time wondering whether their experience was their own fault — whether they recovered too slowly, complained too much, or expected too much from a surgery that was always going to be difficult. The question they are really asking is simpler: was what happened to me avoidable? That is a question worth answering honestly.
Dr Listing examines the medical records alongside expert clinical opinion to give that honest answer — whatever it turns out to be. Where the evidence supports a claim, she pursues it with the full weight of both her clinical understanding and her legal expertise. Where it does not, she says so clearly — because the people who come to her deserve the truth, not false hope.
- Exactech Inc., Voluntary Recall Notice — Polyethylene Inserts (Knee, Hip and Ankle Systems), February 2022. Exactech confirmed that affected devices were packaged in bags that did not conform to the required oxygen barrier specification, resulting in oxidative degradation of polyethylene components.
- Therapeutic Goods Administration (TGA), Medical Device Recall Database — Exactech knee system recall actions, 2022. Available at: www.tga.gov.au/resources/recalls-database. Recall reference numbers for affected Exactech knee product lines are listed in the TGA database.
- Australian Consumer Law (Schedule 2 to the Competition and Consumer Act 2010 (Cth)), ss 54–56 (acceptable quality and fitness for purpose obligations for goods); s 9 (safety defect provisions for goods).
- Therapeutic Goods (Medical Devices) Regulations 2002 (Cth), reg 5.8 (recall obligations); TGA, Uniform Recall Procedure for Therapeutic Goods (URPTG), 6th edition.
- Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), Annual Report 2023. Available at: aoanjrr.sahmri.com. Revision surgery figures cited are drawn from the AOANJRR national dataset for knee arthroplasty.
- Exactech Inc., Recall Notice (2022), ibid. The notice confirmed that the non-conforming packaging was used across multiple product lines over an extended period, and that the defect was identified through internal quality review and post-market surveillance data.
- United States Food and Drug Administration (FDA), Medical Device Recall Database — Exactech recall classification and supporting documentation, 2022. Available at: www.fda.gov/medical-devices/medical-device-recalls.
- Competition and Consumer Act 2010 (Cth), Schedule 2 (Australian Consumer Law), Part 3-5 (liability of manufacturers for goods with safety defects). Liability under Part 3-5 is strict — it does not require proof of negligence.
- Competition and Consumer Act 2010 (Cth), Schedule 2, s 7 (definition of manufacturer, including importers and persons who hold themselves out as manufacturers); s 138 (liability of manufacturers for injuries caused by safety defects).
- Competition and Consumer Act 2010 (Cth), Schedule 2, s 9 (safety defect defined by reference to the safety persons generally are entitled to expect); s 138 (action against manufacturer for death or personal injury).
- Pain and suffering (non-economic loss) damages thresholds are set by state and territory civil liability legislation. Relevant statutes include: Civil Liability Act 2002 (NSW), s 16; Wrongs Act 1958 (Vic), s 28G; Civil Liability Act 2003 (Qld), s 62; Civil Liability Act 1936 (SA), s 52; Civil Liability Act 2002 (WA), s 10; Civil Liability Act 2002 (Tas), s 27; Civil Law (Wrongs) Act 2002 (ACT), s 99; Personal Injuries (Liabilities and Damages) Act 2003 (NT), s 27.
- Limitation periods for personal injury and product liability claims are governed by state and territory limitation legislation, including: Limitation Act 1969 (NSW), s 14 and s 50C (discovery rule); Limitation of Actions Act 1958 (Vic), s 27D; Limitation of Actions Act 1974 (Qld), s 11 and s 30; Limitation Act 2005 (WA), s 14; Limitation of Actions Act 1936 (SA), s 36; Limitation Act 1974 (Tas), s 5; Limitation Act 1985 (ACT), s 16B; Limitation Act 1981 (NT), s 12. The discovery rule — which starts the limitation period from the date the plaintiff knew or ought reasonably to have known of the harm and its cause — applies in most jurisdictions and is particularly relevant to Exactech patients who were not notified of the recall promptly.
This article contains general legal information only. It does not constitute legal advice, and reading it does not create a lawyer–client relationship. The law discussed applies to Australia. Laws and time limits vary between states and territories, and these differences may affect your position. You should seek independent legal advice about your specific situation.