UPDATE: Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication
Date Issued: June 3, 2026
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers of the elevated long-term risk of device failure, higher-than-expected risk of revision surgery, and risk of polyethylene fracture (plastic breakage) observed in the Hintermann Series H3 Total Ankle Replacement (TAR) System (also referred to as “the H3 TAR system”), manufactured by DT MedTech LLC (also known as Hintegra by the previous manufacturer NewDeal/Integra Life).
Based on our current assessment of the totality of data, we are updating our recommendations to patients, caregivers, surgeons, and health care providers. We recommend considering using other available treatment options where possible. The FDA continues to review available data from mandated postmarket studies, scientific literature, and other real-world data sources, including registry data, adverse event reporting, and information from the manufacturer. The FDA Summary of Key Findings section provides more detailed information regarding this data.
Recommendations for Patients and Caregivers
Patients who are considering the H3 TAR system
- Discuss with your health care provider all available treatment options for your painful arthritic ankle. When surgery is selected as an option, make sure that you understand the benefits and risks of ankle fusion (arthrodesis) and other ankle replacement devices available to you.
- Be aware of the long-term risk of device failure and need for additional surgery with the H3 TAR system. If your health care provider recommends the H3 TAR system, ask them why it is the right treatment option for your specific situation, considering other available ankle replacement devices.
Patients who have the TAR system
- If your H3 TAR system is functioning well, and you have no new or worsening pain or symptoms, the FDA does not recommend surgery to remove it. Continue with your existing follow-up schedule for your H3 TAR system.
- Contact your health care provider if you are experiencing any of the following:
- any new or worsening pain or swelling in your ankle,
- inability to use your ankle or bear weight,
- instability of your ankle,
- grinding or other unusual noise from your implanted device, or
- weakness around your implanted device.
- Be aware that your health care provider may perform a physical examination of your ankle and obtain X-rays to evaluate it. In some instances, a computed tomography (CT) scan may be necessary to assess if the plastic component in your H3 TAR system is broken.
- Report any problems or complications experienced with your H3 TAR system to the FDA. Your report, combined with information from other sources, helps the FDA identify safety concerns and improve patient safety.
Recommendations for Health Care Providers
Health Care Providers Who Treat Patients with Painful Arthritic Ankle Joints
- Consider using an available alternative treatment option where possible.
- If no alternatives are appropriate, explain the long-term risks of device failure and revision surgery to the patient, and discuss the clinical rationale for selecting this device.
- As part of shared decision-making, discuss the benefits and risks of all available treatment options for painful arthritic ankle joints with your patients.
- When making treatment recommendations, consider the long-term risk of device failure and revision surgery in patients already implanted with the H3 TAR system.
- Refer to the FDA Summary of Key Findings section for more information regarding these recommendations.
Health Care Providers Who Follow Patients with an H3 TAR System
- Closely monitor patients with the H3 TAR system for device problems such as loosening, fractures of the plastic implant component, and polyethylene wear-related complications of the device.
- For suspected device problems, such as component loosening, a fractured plastic component, and polyethylene wear-related complications, consider performing X-rays to further evaluate the device integrity.
- Be aware that changes on X-rays can be subtle. If X-rays are negative and polyethylene fracture is still suspected, a CT scan may be needed to determine whether a plastic component fracture has occurred.
- Be aware that the clinical presentation and the signs or symptoms of fracture in plastic component can be subtle, even on CT imaging.
- Report any problems your patients experience with the H3 TAR system to the FDA.
- Refer to the FDA Summary of Key Findings section for more information regarding these recommendations.
Device Description
The H3 TAR system consists of metallic tibial (lower leg) and talar (ankle) components with a mobile polyethylene (plastic) component. The H3 TAR system is indicated for use as a non-cemented total ankle prosthesis (artificial joint) and used to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic osteoarthritis (arthritis caused by a prior injury), or an inflammatory disease. The device was approved in the United States in 2019 with post-approval studies (PAS) required by the FDA.
FDA Actions
The FDA will continue to work with the manufacturer to ensure that patients, caregivers, surgeons, and health care providers are aware of the long-term risk of device failure, and to identify additional mitigation strategies as needed.
The FDA will continue to keep the public informed if significant new information becomes available.
Timeline of Communication Updates
A timeline and summary of the FDA's previous communications related to this device is provided below.
| Date | Actions |
|---|---|
| 06/03/2026 | The FDA updated this safety communication with additional information regarding the DT MedTech Hintermann Series H3 TAR system and FDA’s recommendation to consider using other available treatment options where possible. |
| 10/31/2025 | The FDA provided an update on post-approval study data for the Hintermann Series H3 TAR system. (Archived Communication) |
| 02/29/2024 | The FDA issued a safety communication about a higher-than-expected risk of device failure with the Hintermann Series H3 TAR system. (Archived Communication) |
Reporting Problems with Your Device
If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Unique Device Identifier
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
You can find the UDI provided by DT MedTech LLC for Hintermann Series H3 TAR systems by checking the table below.
| Version or Model Number | Device Description | Device Identifier Number |
|---|---|---|
| 300105 | H3 PE INLAY SIZE 1 - 5MM | B095300105 |
| 300106 | H3 PE INLAY SIZE 1 - 6MM | B095300106 |
| 300107 | H3 PE INLAY SIZE 1 - 7MM | B095300107 |
| 300109 | H3 PE INLAY SIZE 1 - 9MM | B095300109 |
| 300205 | H3 PE INLAY SIZE 2 - 5MM | B095300205 |
| 300206 | H3 PE INLAY SIZE 2 - 6MM | B095300206 |
| 300207 | H3 PE INLAY SIZE 2 - 7MM | B095300207 |
| 300209 | H3 PE INLAY SIZE 2 - 9MM | B095300209 |
| 300305 | H3 PE INLAY SIZE 3 - 5MM | B095300305 |
| 300306 | H3 PE INLAY SIZE 3 - 6MM | B095300306 |
| 300307 | H3 PE INLAY SIZE 3 - 7MM | B095300307 |
| 300309 | H3 PE INLAY SIZE 3 - 9MM | B095300309 |
| 300405 | H3 PE INLAY SIZE 4 - 5MM | B095300405 |
| 300406 | H3 PE INLAY SIZE 4 - 6MM | B095300406 |
| 300407 | H3 PE INLAY SIZE 4 - 7MM | B095300407 |
| 300409 | H3 PE INLAY SIZE 4 - 9MM | B095300409 |
| 300505 | H3 PE INLAY SIZE 5 - 5MM | B095300505 |
| 300506 | H3 PE INLAY SIZE 5 - 6MM | B095300506 |
| 300507 | H3 PE INLAY SIZE 5 - 7MM | B095300507 |
| 300509 | H3 PE INLAY SIZE 5 - 9MM | B095300509 |
| 300605 | H3 PE INLAY SIZE 6 - 5MM | B095300605 |
| 300606 | H3 PE INLAY SIZE 6 - 6MM | B095300606 |
| 300607 | H3 PE INLAY SIZE 6 - 7MM | B095300607 |
| 300609 | H3 PE INLAY SIZE 6 - 9MM | B095300609 |
| 301111 | TALAR COMPONENT RIGHT SIZE 1 | B095301111 |
| 301112 | TALAR COMPONENT RIGHT SIZE 2 | B095301112 |
| 301113 | TALAR COMPONENT RIGHT SIZE 3 | B095301113 |
| 301114 | TALAR COMPONENT RIGHT SIZE 4 | B095301114 |
| 301115 | TALAR COMPONENT RIGHT SIZE 5 | B095301115 |
| 301116 | TALAR COMPONENT RIGHT SIZE 6 | B095301116 |
| 301121 | FC TALAR COMPONENT RIGHT SIZE 1 | B095301121 |
| 301122 | FC TALAR COMPONENT RIGHT SIZE 2 | B095301122 |
| 301123 | FC TALAR COMPONENT RIGHTSIZE 3 | B095301123 |
| 301124 | FC TALAR COMPONENT RIGHT SIZE 4 | B095301124 |
| 301125 | FC TALAR COMPONENT RIGHT SIZE 5 | B095301125 |
| 301201 | H3 TIBIAL COMPONENT RIGHT SIZE 1 | B095301201 |
| 301202 | H3 TIBIAL COMPONENT RIGHT SIZE 2 | B095301202 |
| 301203 | H3 TIBIAL COMPONENT RIGHT SIZE 3 | B095301203 |
| 301204 | H3 TIBIAL COMPONENT RIGHT SIZE 4 | B095301204 |
| 301205 | H3 TIBIAL COMPONENT RIGHT SIZE 5 | B095301205 |
| 301206 | H3 TIBIAL COMPONENT RIGHT SIZE 6 | B095301206 |
| 302111 | TALAR COMPONENT LEFT SIZE 1 | B095302111 |
| 302112 | TALAR COMPONENT LEFT SIZE 2 | B095302112 |
| 302113 | TALAR COMPONENT LEFT SIZE 3 | B095302113 |
| 302114 | TALAR COMPONENT LEFT SIZE 4 | B095302114 |
| 302115 | TALAR COMPONENT LEFT SIZE 5 | B095302115 |
| 302116 | TALAR COMPONENT LEFT SIZE 6 | B095302116 |
| 302121 | FC TALAR COMPONENT LEFT SIZE 1 | B095302121 |
| 302122 | FC TALAR COMPONENT LEFT SIZE 2 | B095302122 |
| 302123 | FC TALAR COMPONENT LEFT SIZE 3 | B095302123 |
| 302124 | FC TALAR COMPONENT LEFT SIZE 4 | B095302124 |
| 302125 | FC TALAR COMPONENT LEFT SIZE 5 | B095302125 |
| 302201 | H3 TIBIAL COMPONENT LEFT SIZE 1 | B095302201 |
| 302202 | H3 TIBIAL COMPONENT LEFT SIZE 2 | B095302202 |
| 302203 | H3 TIBIAL COMPONENT LEFT SIZE 3 | B095302203 |
| 302204 | H3 TIBIAL COMPONENT LEFT SIZE 4 | B095302204 |
| 302205 | H3 TIBIAL COMPONENT LEFT SIZE 5 | B095302205 |
| 302206 | H3 TIBIAL COMPONENT LEFT SIZE 6 | B095302206 |
Questions?
If you have questions, contact CDRH's Division of Industry and Consumer Education (DICE).
FDA Summary of Key Findings
FDA Mandated Post-Approval Study
The manufacturer submitted the final post-approval study report from a prospective cohort study tracking patients from the original premarket clinical studies to 10 years, with an enrollment of 280 patients from Switzerland. The study found that 31.8% of patients received revision surgery at 10 years (95% CI: 26.0%,38.4%), compared to 19.2% at 5 years (95% CI:14.9%, 24.5%), including both metal and polyethylene components. Excluding revision of polyethylene alone, 14.9% of patients needed surgery to remove or revise metal components at 10 years (95% CI: 10.5%, 21.0%), compared to 6.5% at 5 years (95% CI: 4.0%, 10.4%). These rates were estimated using survival analysis methods applied to time-to-revision data for enrolled patients.
The study had significant data limitations: 69.6% (179/257) and 55.7% (122/219) of patients were lost to follow-up at 5 years and 10 years respectively, which may affect the reliability of the long-term estimates. The complete data summary is available on the FDA post-approval study webpage at FDA post-approval study.
Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR)
Based on data from the Australian Orthopaedic Association's National Joint Replacement Registry (AOANJRR) 2025 Hintermann Series H3/Hintermann Series H3 Total Ankle Investigation report [PDF – 185 KB], the registry analysis included 573 H3 TAR systems (with 108 revised) and 4,806 other total ankle replacement devices (with 316 revised), implanted in Australia through 2024. The cumulative revision rate over 15 years for the H3 TAR system was 25.7% compared to 15.2% for all other total ankle replacement devices.
The H3 TAR system showed a statistically significantly higher risk of revision compared to other total ankle replacement devices (Hazard Ratio 1.93, 95% confidence interval: 1.55–2.40; p-value <0.001) after adjusting for age and sex.
See the excerpted figure from the source data below:
Source: Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Hintermann Series H3/Hintermann Series H3 Total Ankle Investigation, Figure 1, AOA, Adelaide, 2025: 1-9. Accessed from https://aoanjrr.sahmri.com/documents/d/guest/hintermann-series-h3-hintermann-series-h3-combination-2025-1?download=false.
The 10-year cumulative incidence of revision due to polyethylene fracture was approximately four times as high as that for all other devices (see below Figure 2: Cumulative Incidence Revision Diagnosis for Primary Total Ankle Replacement). Polyethylene fracture was the second most common reason for revision of the H3 TAR system, while it was the fifth most common reason for revision among all other primary replacement devices at 10-year follow-up.
The most common reasons for revision procedures in the Hintermann Series H3 TAR system group were:
- Loosening (25.0%)
- Polyethylene breakage (16.7%)
- Infection (10.2%)
- Instability (10.2%)
- Pain (8.3%)
- Lysis (8.3%)
The most common reasons for revision procedures among all other total ankle replacement devices were:
- Loosening (35.8%)
- Infection (15.8%)
- Lysis (9.8%)
- Instability (7.3%)
- Polyethylene breakage (6.3%)
Providers should note that the AOANJRR data reflect Australian implantation practices, which may differ from U.S. practice in areas such as patient selection criteria, surgeon volume, and rehabilitation protocols. These differences should be considered when applying these findings to U.S. patient populations.
Source: Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Hintermann Series H3/Hintermann Series H3 Total Ankle Investigation, Figure 1, AOA, Adelaide, 2025: 1-9. Accessed from https://aoanjrr.sahmri.com/documents/d/guest/hintermann-series-h3-hintermann-series-h3-combination-2025-1?download=false.
The FDA is aware that the Australian Government's Therapeutic Goods Administration (TGA) issued a market action regarding this device on February 12, 2026, citing the increased risk of revision shown in the registry data. Effective May 5, 2026, the TGA no longer allows for the sale or distribution of the H3 TAR system in Australia. Actis Medical Pty Ltd acts as the Australian sponsor and regulatory agent for DT MedTech LLC products.
United Kingdom National Joint Registry (UK NJR)
Based on data from the United Kingdom (UK) National Joint Registry (NJR) 2025 Annual Report, an analysis of total ankle replacement devices implanted in the UK indicated the cumulative revision rate for the H3 TAR system was 9.5% (95% confidence interval: 6.6%, 13.7%) at 10 years compared to the rate at 5 years which was 5.0% (95% confidence interval: 3.1%, 8.1%). The NJR has identified limitations with their ankle data. The report notes that up to one-third of ankle revisions in the UK are not reported to the registry. See the UK NJR data: NJR 22nd Annual Report 2025_Ankles. [PDF – 9,160 KB] (September 2025).
Conclusion for Health Care Providers
The FDA Mandated Post-Approval Study, the Australian AOANJRR, and the UK NJR show increased long-term rates of revision surgery and device failure associated with the H3 TAR system. The FDA encourages health care providers to independently evaluate the available evidence.