Devices › Prosthesis, ankle, semi-constrained, cemented, metal/polymer
Device brand name · Prosthesis ankle semi-constrained cemented metal/polymer
Unknown Tibial Component: medical device reports filed with FDA
832 reports name it, 2005–2026. Manufacturer given most often on reports: Wright Medical Technology. Product code HSN.
- 832
- device reports naming the brand
- 0% of all MAUDE reports · about 39 a year
- 200
- reports, 12 months to August 2026
- 143 in the 12 months before
- 0.5%
- classified as malfunction
- 3.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 832 reports that name the brand "Unknown Tibial Component" (prosthesis ankle semi-constrained cemented metal/polymer), received between March 2005 and August 2026; the manufacturer given most often on reports is Wright Medical Technology. Spellings of one product vary from report to report.
200 reports arrived in the 12 months to August 2026, up 40% from 143 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 (99.5%) and malfunction (0.5%); across all prosthesis, ankle, semi-constrained, cemented, metal/polymer reports (product code HSN) death is recorded in 0% and malfunction in 3.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are osseointegration problem (24.5%), insufficient device problem information (21.9%) and migration (8.1%). The patient problems coded most often are inadequate osseointegration, cyst(s) 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 7,103 reports carrying product code HSN. 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 |
|---|---|---|---|
| Osseointegration problem | 204 | 24.5% | 16.8% |
| Insufficient device problem information | 182 | 21.9% | 21.6% |
| Migrationthe device moved from where it was placed | 67 | 8.1% | 7.9% |
| Loosening of implant not related to bone-ingrowth | 57 | 6.9% | 1.4% |
| Loss of osseointegration | 53 | 6.4% | 4.9% |
| Implant subsidence | 39 | 4.7% | 2.1% |
| Fracturea broken bone | 31 | 3.7% | 2.4% |
| Unstable | 14 | 1.7% | 0.7% |
| Migration or expulsion of device | 13 | 1.6% | 1.1% |
| Malposition of device | 12 | 1.4% | 1.1% |
| Device dislodged or dislocated | 8 | 1% | 0.9% |
| Inadequacy of device shape and/or size | 8 | 1% | 0.7% |
| Loss of or failure to bond | 4 | 0.5% | 0.8% |
| Material erosion | 4 | 0.5% | 0% |
| Breakthe device broke | 3 | 0.4% | 1.7% |
| Collapse | 3 | 0.4% | 0.1% |
| Naturally worn | 3 | 0.4% | 2.7% |
| Mechanical problema mechanical problem | 2 | 0.2% | 0.1% |
| Crackthe device cracked | 1 | 0.1% | 0% |
| Defective devicethe device was defective | 1 | 0.1% | 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 |
|---|---|---|
| Inadequate osseointegration | 243 | 29.2% |
| Cyst(s) | 141 | 16.9% |
| Painpain, site not specified | 139 | 16.7% |
| Injurya physical injury | 126 | 15.1% |
| Failure of implant | 69 | 8.3% |
| Bone fracture(s) | 41 | 4.9% |
| Osteolysis | 38 | 4.6% |
| Implant pain | 24 | 2.9% |
| Loss of range of motion | 21 | 2.5% |
| Swelling/ edema | 17 | 2% |
| Aseptic loosening | 16 | 1.9% |
| Joint laxity | 16 | 1.9% |
| Ambulation or postural difficulties | 15 | 1.8% |
| Post operative wound infection | 13 | 1.6% |
| Impaired healingslow healing | 12 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Tibial Component | Product code HSN | All MAUDE reports |
|---|---|---|---|
| Reports | 832 | 7,103 | 26,136,888 |
| Share of that pool | — | 11.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 99.5% | 96.4% | 36.2% |
| Classified as malfunction | 0.5% | 3.4% | 62.3% |
| Filed by the manufacturer | 100% | 99.1% | 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 HSN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Infinity Total Ankle System | 401 | 0 | 0% |
| Unknown Talar component | 528 | 149 | 1.1% |
| Unknown Total Ankle System | 354 | 88 | 0% |
| Unknown Total Ankle Replacement | 185 | 161 | 0% |
| Inbone Total Ankle System | 150 | 0 | 0% |
| Star Total Ankle Replacement | 242 | 0 | 0% |
| Unknown Star Talar Component | 212 | 0 | 0% |
| Unknown Bearing | 317 | 84 | 0.3% |
| Infinity | 193 | 24 | 2.1% |
| Quantum | 183 | 35 | 0.5% |
| Unknown Tibial Tray | 405 | 25 | 0.2% |
| Unknown Depuy Tibial Insert | 728 | 0 | 0% |
| Dow Corning | 297 | 0 | 0.7% |
| Jgrknt 1 0mm Mini 3-0 Ndls | 218 | 3 | 0% |
| UNK Attune Knee Patella | 239 | 23 | 0.4% |
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 Unknown Tibial Component reports
How many FDA reports name Unknown Tibial Component?
832 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 200 in the latest 12 months.
What kinds of events are reported?
injury (99.5%) and malfunction (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
osseointegration problem (24.5%), insufficient device problem information (21.9%), migration (8.1%), loosening of implant not related to bone-ingrowth (6.9%) and loss of osseointegration (6.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Unknown Tibial Component 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.