Devices › Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
Device brand name · Unicondylar knee replacement system
Iuni G2: medical device reports filed with FDA
210 reports name it, 2010–2020. Manufacturer given most often on reports: Conformis. Product code HSX.
- 210
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 8.6%
- classified as malfunction
- 21.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
210 medical device reports received by FDA name the brand "Iuni G2" (unicondylar knee replacement system); the manufacturer given most often on reports is Conformis; received from July 2010 to November 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (91.4%) and malfunction (8.6%); across all prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer reports (product code HSX) death is recorded in 0% and malfunction in 21.7%. 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 (34.3%), device slipped (6.7%) and loose or intermittent connection (5.7%). The patient problems coded most often are pain, fall and bone fracture(s). 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 Iuni G2 was received in the five years to August 2026; the latest was received in November 2020.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,538 reports carrying product code HSX. 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 | 72 | 34.3% | 13.8% |
| Device slipped | 14 | 6.7% | 2.1% |
| Loose or intermittent connection | 12 | 5.7% | 2% |
| Device operates differently than expectedthe device behaved unexpectedly | 8 | 3.8% | 0.9% |
| Breakthe device broke | 7 | 3.3% | 8.4% |
| Fitting problem | 4 | 1.9% | 0.8% |
| Device dislodged or dislocated | 3 | 1.4% | 1.9% |
| Fracturea broken bone | 3 | 1.4% | 11.5% |
| Human-device interface problem | 3 | 1.4% | 0.2% |
| Unstable | 3 | 1.4% | 1.5% |
| Detachment of device component | 2 | 1% | 0.5% |
| Difficult to insertthe device was hard to insert | 2 | 1% | 1.4% |
| Failure to adhere or bond | 2 | 1% | 0.7% |
| Incorrect device or component shipped | 2 | 1% | 0.1% |
| Malposition of device | 2 | 1% | 0.9% |
| Device misassembled during manufacturing /shipping | 1 | 0.5% | 0% |
| Device-device incompatibility | 1 | 0.5% | 0.1% |
| Incomplete or missing packaging | 1 | 0.5% | 0% |
| Material rupture | 1 | 0.5% | 0.1% |
| Mechanical problema mechanical problem | 1 | 0.5% | 0.2% |
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 |
|---|---|---|
| Painpain, site not specified | 23 | 11% |
| Falla fall | 9 | 4.3% |
| Bone fracture(s) | 3 | 1.4% |
| Limited mobility of the implanted joint | 3 | 1.4% |
| Complaint, ill-defined | 2 | 1% |
| Failure of implant | 2 | 1% |
| Joint dislocationa dislocated joint | 2 | 1% |
| Tissue damage | 2 | 1% |
| Ambulation or postural difficulties | 1 | 0.5% |
| Anemialow red blood cells | 1 | 0.5% |
| Arthritis | 1 | 0.5% |
| Bacterial infectiona bacterial infection | 1 | 0.5% |
| Hemorrhage/blood loss/bleeding | 1 | 0.5% |
| Hypersensitivity/allergic reaction | 1 | 0.5% |
| Impaired healingslow healing | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Iuni G2 | Product code HSX | All MAUDE reports |
|---|---|---|---|
| Reports | 210 | 2,538 | 26,136,888 |
| Share of that pool | — | 8.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 91.4% | 77.3% | 36.2% |
| Classified as malfunction | 8.6% | 21.7% | 62.3% |
| Filed by the manufacturer | 99.5% | 98.9% | 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 HSX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Itotal G2 | 1,250 | 0 | 0% |
| Unkn Orthopaedic Reconstruction Dev | 239 | 17 | 0.4% |
| Unknown Femoral Component | 642 | 90 | 0.3% |
| Unknown Articular Surface | 473 | 78 | 0% |
| Genesis | 1,648 | 0 | 0.1% |
| Unknown Stryker knee | 194 | 17 | 0.5% |
| Real Intelligence Cori | 983 | 97 | 0% |
| Unknown Depuy Cement | 394 | 0 | 0.3% |
| Unknown Femoral | 204 | 27 | 0% |
| Unknown Knee Implant | 579 | 16 | 0% |
| Unknown Persona Femoral Component | 193 | 87 | 0% |
| Unknown Reconstructive Product | 2,579 | 0 | 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 Iuni G2 reports
How many FDA reports name Iuni G2?
210 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 (91.4%) and malfunction (8.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (34.3%), device slipped (6.7%), loose or intermittent connection (5.7%), device operates differently than expected (3.8%) and break (3.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Iuni G2 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.