Devices › Prosthesis, ankle, uncemented, non-constrained
Device brand name · Star sliding core
Star Total Ankle Replacement: medical device reports filed with FDA
242 reports name it, 2009–2015. Product code NTG.
- 242
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0%
- classified as malfunction
- 5.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 242 reports that name the brand "Star Total Ankle Replacement" (star sliding core), received between July 2009 and March 2015. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (100%); across all prosthesis, ankle, uncemented, non-constrained reports (product code NTG) death is recorded in 1.1% and malfunction in 5.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (44.6%), fracture (10.3%) and unintended movement (4.1%). The patient problems coded most often are arthritis, failure of implant and pain. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Star Total Ankle Replacement was received in the five years to August 2026; the latest was received in March 2015.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,693 reports carrying product code NTG. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Insufficient device problem information | 108 | 44.6% | 11.4% |
| Fracturea broken bone | 25 | 10.3% | 8.1% |
| Unintended movement | 10 | 4.1% | 0.8% |
| Patient-device incompatibilitythe device did not suit the patient | 8 | 3.3% | 0.9% |
| Improper or incorrect procedure or method | 6 | 2.5% | 0.6% |
| Naturally worn | 6 | 2.5% | 3.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 2.1% | 1.7% |
| Device slipped | 5 | 2.1% | 1.1% |
| Inadequacy of device shape and/or size | 5 | 2.1% | 1.7% |
| Migration or expulsion of device | 5 | 2.1% | 0.5% |
| Breakthe device broke | 4 | 1.7% | 6.3% |
| Device dislodged or dislocated | 4 | 1.7% | 1.5% |
| Degraded | 3 | 1.2% | 0.2% |
| Failure to osseointegrate | 3 | 1.2% | 0.2% |
| Material deformation | 2 | 0.8% | 0.5% |
| Material erosion | 2 | 0.8% | 0.1% |
| Component(s), broken | 1 | 0.4% | 0% |
| Implant, removal of | 1 | 0.4% | 0% |
| Malposition of device | 1 | 0.4% | 2.4% |
| Positioning problem | 1 | 0.4% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Arthritis | 37 | 15.3% |
| Failure of implant | 36 | 14.9% |
| Painpain, site not specified | 22 | 9.1% |
| Bone fracture(s) | 10 | 4.1% |
| Cyst(s) | 10 | 4.1% |
| Inadequate osseointegration | 9 | 3.7% |
| Extraskeletal ossification | 4 | 1.7% |
| Limited mobility of the implanted joint | 4 | 1.7% |
| Falla fall | 2 | 0.8% |
| Joint disorder | 2 | 0.8% |
| Arthralgiajoint pain | 1 | 0.4% |
| Congenital defect/deformity | 1 | 0.4% |
| Inadequate pain relief | 1 | 0.4% |
| Inflammationinflammation | 1 | 0.4% |
| Joint swellinga swollen joint | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Star Total Ankle Replacement | Product code NTG | All MAUDE reports |
|---|---|---|---|
| Reports | 242 | 1,693 | 26,136,888 |
| Share of that pool | — | 14.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 11 | 9 |
| Classified as injury | 100% | 93.4% | 36.2% |
| Classified as malfunction | 0% | 5.5% | 62.3% |
| Filed by the manufacturer | 66.1% | 96% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code NTG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Star Talar Component | 212 | 0 | 0% |
| Unknown Talar component | 528 | 149 | 1.1% |
| Unknown Tibial Component | 832 | 200 | 0% |
| Star | 520 | 50 | 0% |
| Unknown Articular Surface | 473 | 78 | 0% |
| Altivate Reverse Shoulder | 500 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Star Total Ankle Replacement reports
How many FDA reports name Star Total Ankle Replacement?
242 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (44.6%), fracture (10.3%), unintended movement (4.1%), patient-device incompatibility (3.3%) and improper or incorrect procedure or method (2.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (66.1%) and distributor reports (33.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Star Total Ankle Replacement was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.