Ethical Considerations in Disclosing Orthopedic Implant Failures to Patients

Background

With an aging population, the volume of orthopedic surgeries requiring implants performed yearly will continue to grow. For example, the projected annual growth in total hip arthroplasty (THA) and total knee arthroplasty is 9% and 36%, respectively, by 2060. ¹ The associated growing orthopedic implant market was valued at approximately $60 billion in 2023 and projected to rise to $80 billion by 2030. ² With increasing use of novel implant technologies, orthopedics continues to evolve at a rapid pace, providing opportunities for care improvement but also device failures. Since the passage of the Medical Device Amendments of 1976, the US Food and Drug Administration (FDA) regulates medical devices through premarket notification, premarket approval, adverse event reporting, and post-market monitoring.

Medical devices, while a hallmark of orthopedic surgery, can malfunction, with potentially devastating clinical consequences. Such malfunctions may lead to device recall, which can have a considerable impact on patient outcomes, the doctor-patient relationship, and the reputation and profitability of device companies. Typically, medical device recalls are initiated by the manufacturer, although the FDA has legal authority to recall a device if required. ³ Orthopedic device recalls constitute a substantial percentage of total medical device recalls, ranging from 12% to 22% between 2015 and 2019. ³

Surgeons need the skills and tools to educate, reassure, and manage patients’ safety when it comes to implants. Orthopedic surgeons may also face a unique dilemma when they experience an implant malfunction with no sanctioned recall on the device. This commentary explores the ethical considerations that orthopedic surgeons must address when deciding whether to act upon individual cases of implant failure, and if so, what steps can be taken to protect patients. This includes evaluating the benefits of early disclosure against the risks of causing undue psychological distress to patients.

Case Example

A 45-year-old woman with a history of anxiety underwent 2-level anterior cervical discectomy and fusion for cervical radiculopathy (this case is a fictional example based on our clinical experience). Her surgery was uneventful, and a polyether-ether-ketone cage and titanium plate/screw construct was utilized. She presents for a routine 3-month follow-up appointment with her spine surgeon, where she reports doing well in terms of neck and arm pain. The surgeon notes on radiographs that there is failure of the screw locking mechanism with early screw backout, which he has observed in several other patients with whom he has used this same plate. In the surgeon’s experience, fewer than 25% of those cases were symptomatic and ultimately required revision surgery, as most patients fused well with asymptomatic minor screw backout. The surgeon has stopped using that plate after the series of locking mechanism failures and considers informing the patient about the issue, despite concerns that informing her may lead to undue anxiety, given that she is reporting less pain and will most likely fuse. Although the surgeon reported the failures to the implant company and hospital, there has not been an official implant recall. This scenario highlights the ethical tension that may arise when a surgeon has experience of implant failure, balancing the principles of respect for patient autonomy, duty to inform, and non-maleficence.

Ethical Principles

Autonomy, Benefice, Non-maleficence, and Justice

One of the core principles of medical ethics is respect for patient autonomy. Autonomy involves the patient’s right to make informed decisions about a treatment based on their individual beliefs and preferences. ⁴ Patients with demonstrated capacity for clinical decision making should feel empowered to receive pertinent details regarding their surgery, including the consequences and possible complications of the implants involved. This supports the informed consent process and establishes a basis for common questions asked by patients in the pre-operative appointment. Respect for patient autonomy aids in maintaining the patient-doctor relationship, and this may be extended to disclosure of potential harm if a surgeon has concerns about an orthopedic implant. Similarly, surgeons have an obligation to avoid harm, also termed non-maleficence ⁵ (Table 1). Using these tenets of medical ethics, a surgeon may be inclined to report concerns of a possible malfunctioning device to the manufacturer and inform other patients of this possibility, even if there has not been a formal recall.

Table 1.

The 4 Principles of Medical Ethics.

Principle	Definition	Application to clinical scenario
Autonomy	Duty to respect patient’s right to make their own informed decisions	Surgeons should inform patients preoperatively regarding risks of orthopedic implants and transparently discuss if there is concern with an implant
Non-maleficence	Duty to do no harm to the patient	Surgeons should protect patients in the event of implant failure. This may involve surveillance imaging, laboratory tests, and revision surgery if indicated
Beneficence	Duty to act in the patient’s best interest	Surgeons should assess the benefit of disclosure, as compared to the risk of potential psychological distress. This depends on the seriousness of the implant failure, probability of occurrence, other patient and surgical factors, and the patient’s symptoms
Justice	Duty to treat all patients fairly and equitably	Surgeons should ensure all patients affected by an implant failure are able to discuss the implications with a healthcare provider. The cost of care may be distributed across device manufacturers, private insurance companies, and Medicare, if applicable

Therapeutic Privilege

An important caveat to consider in disclosing information regarding possible implant failure is the psychological effect on patients. Therapeutic privilege refers to withholding information as disclosure would inflict harm and is not in the best interest of the patient. ⁶ It is considered an exception to the general rule of informed consent but, from a patient perspective, may be applicable in select scenarios. Patients with chronic neck and back pain commonly have associated psychological comorbidities, with 1 study reporting 59% of patients with chronic low back pain also meeting criteria for a psychiatric comorbidity, most commonly major depression followed by substance use disorder. ⁷ If a patient is asymptomatic and there is no evidence for harm due to minor implant failure in the setting of a solid fusion, then disclosure of concerns may inflict unnecessarily psychological distress. ⁶ Psychological distress may in turn lead to psychosomatic symptoms that can be disturbing for patients and challenging for surgeons to distinguish from functional pathology related to implant failure.

Professional Obligations and Product Recall

When an implant is recalled, orthopedic surgeons should engage with their affected patients and discuss management plans. Device recall can be initiated by the FDA under statutory authority if there is concern for public harm, although most product recalls are carried out under the manufacturer’s own initiative. ⁸ The FDA provides oversight and monitoring for the ensuing steps. Commonly, the associated costs of the recall process (from evaluation to possible revision surgery) are managed by the manufacturer in conjunction with private insurance companies and Medicare to reduce financial burden on patients. ⁹

The FDA classifies product recalls as class I to III, depending on the probability of harm caused by product use; class I refers to the most serious risk of patient harm. ¹⁰ The American Academy of Orthopaedic Surgeons (AAOS) has developed an online “dashboard” with devices that are currently under recall. ¹¹ All recalls listed are considered class II, having a remote probability of adverse patient consequences. Currently, arthroplasty devices represent 272 out of 479 product recalls (57%; Table 2). Surgeons are also able to access the Manufacturer and User Facility Device Experience database, which contains medical device reports of adverse events. ¹² This provides an important tool for monitoring safety issues related to medical devices.

Table 2.

Implant Recalls, per Orthopedic Subspeciality, as of October 2025 (479 Total Devices, Devices May Be Listed Under Multiple Subspecialities per FDA Approved Use). All Recalls Listed Are Class 2.

Specialty	Number of total recalls	Percentage of recalls
Arthroplasty	272	56.78%
Trauma	83	17.33%
Spine	54	11.27%
Shoulder and elbow	50	10.44%
Sports	29	6.05%
Foot and ankle	27	5.64%
Hand	13	2.71%
Pediatrics	10	2.09%

Abbreviation: FDA, Food and Drug Administration.

The AAOS provides an information statement to assist surgeons when faced with situations surrounding product recall, including the following 5 principles ¹³ :

1. Awareness of device recalls and the potential associated harms.

2. Reporting incidents of adverse events related to medical implants via the FDA.

3. Cooperation with both manufacturers and hospitals in notifying patients of the recall.

4. Pursuing shared decision making with patients, including discussion of pain, disability, morbidity, and mortality related to implant retention or revision surgery.

5. Maintaining future surveillance and monitoring patients for changes in clinical status.

Critically, the AAOS recommends that, in consultation with the patient, clinicians should use their professional judgment to determine the best course of treatment.

Implant Failure: The Case of the DePuy Articular Surface Replacement

In 2010, DePuy issued a voluntary recall on its articular surface replacement (ASR) metal-on-metal hip implant. ¹⁴ Concerns were raised after joint registry data suggested these implants were failing prematurely. For example, the National Registry of England and Wales reported an all-cause 5 year revision rate of 12% for the hip resurfacing system and 13% for the THA system. ¹⁵ Several flaws were identified, including the small size of the acetabular cup and femoral head, resulting in increased frictional wear, and the release of metal debris and ions. ¹⁶ DePuy initially challenged the data, although it eventually recalled 93 000 devices worldwide. The failure of metal-on-metal bearing surfaces has led to at 33 452 cases filed as of 2026. ¹⁷

The ASR event raises questions on how surgeons should, firstly, raise concerns to the appropriate agency in the face of implant failures and, secondly, how to discuss management options with patients. An article in the New York Times highlighted several reasons why surgeons failed to report concerns to the FDA and manufactures, including financial conflicts of interest and fear of litigation. ¹⁸ One surgeon, quoted in the article, said that when openly raising concern for a hip implant, the first response from the medical community was to question his ability as a surgeon.

Moreover, the events surrounding the metal-on-metal implants accentuate underlying principles that a surgeon can make use of in protecting patients from harm. For instance, when a patient presents with pain in the setting of a metal-on-metal prosthesis, it is important to radiographically assess for implant loosening and soft tissue masses, in addition to laboratory tests for infection (C-reactive protein, erythrocyte sedimentation rate) and metallosis (cobalt and chromium serum ions). ¹⁹ This can enable an informed decision-making process on the risks and benefits of revision surgery. Even in asymptomatic patients, some professional groups advocate for yearly evaluation and measurement of serum ions. ²⁰ Bitar et al performed a qualitative study of patients living with ASR implants who were asymptomatic and did not undergo revision surgery. Most patients were satisfied with annual exams and serial testing of metal concentrations, as it provided a sense of security. ²¹ Reassuringly, no patients felt that their trust toward the healthcare system had changed after the implant recall, which highlights the positive impact of transparency and shared decision-making.

Conclusion

When a surgeon has concerns that an implant may be failing at unacceptable rates, reporting to the manufacturer and FDA is encouraged as a first step. Prior to device recall, there is a nuanced balance between transparent disclosure with a patient and avoiding undue and perhaps unnecessary psychological distress. If there is actionable change, such as monitoring of metal ions or close radiographic follow-up, then the patient should be notified even in the absence of symptoms. With regard to the initial clinical scenario that we have presented, the surgeon discussed with the patient that prior implant issues had occurred, and he recommended interval radiographs with regular follow-up, but no further surgical intervention. At the 2-year appointment, radiographs demonstrate solid bony fusion, and the patient remaines asymptomatic.