Devices › Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Device brand name · Tibial poly spacer
ELEOS Limb Salvage System: medical device reports filed with FDA
1,037 reports name it, 2022–2026. Manufacturer given most often on reports: Onkos Surgical. Product code KRO.
- 1,037
- device reports naming the brand
- 0% of all MAUDE reports · about 239 a year
- 453
- reports, 12 months to August 2026
- 270 in the 12 months before
- 0.9%
- classified as malfunction
- 10.5% across the product code
- 0.9%
- classified as death, as reported
- 9 reports · not verified by FDA
1,037 medical device reports received by FDA name the brand "ELEOS Limb Salvage System" (tibial poly spacer); the manufacturer given most often on reports is Onkos Surgical; received from March 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
453 reports arrived in the 12 months to August 2026, up 68% from 270 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 (98.3%), death (0.9%) and malfunction (0.9%); across all prosthesis, knee, femorotibial, constrained, cemented, metal/polymer reports (product code KRO) death is recorded in 0.6% and malfunction in 10.5%. 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 (7.2%), device appears to trigger rejection (2.4%) and patient device interaction problem (2.1%). The patient problems coded most often are medical device site infection, joint dislocation and joint laxity. 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 9,412 reports carrying product code KRO. 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 | 75 | 7.2% | 15.8% |
| Device appears to trigger rejection | 25 | 2.4% | 1.4% |
| Patient device interaction problem | 22 | 2.1% | 0.9% |
| Loosening of implant not related to bone-ingrowth | 20 | 1.9% | 3.3% |
| Patient-device incompatibilitythe device did not suit the patient | 20 | 1.9% | 1% |
| Loss of osseointegration | 9 | 0.9% | 4% |
| Osseointegration problem | 7 | 0.7% | 0.7% |
| Unstable | 5 | 0.5% | 3.3% |
| Device difficult to maintain | 4 | 0.4% | 0% |
| Human-device interface problem | 4 | 0.4% | 0% |
| Improper or incorrect procedure or method | 4 | 0.4% | 0.3% |
| Device dislodged or dislocated | 3 | 0.3% | 4.4% |
| Fitting problem | 3 | 0.3% | 0.3% |
| Loose or intermittent connection | 3 | 0.3% | 1.5% |
| Detachment of device or device componentpart of the device came off | 2 | 0.2% | 2.8% |
| Unintended movement | 2 | 0.2% | 0.7% |
| Connection problema connection problem | 1 | 0.1% | 0.1% |
| Delivered as unsterile product | 1 | 0.1% | 0.3% |
| Device damaged prior to receipt by user | 1 | 0.1% | 0.1% |
| Fracturea broken bone | 1 | 0.1% | 9.7% |
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 |
|---|---|---|
| Medical device site infectioninfection at the device site | 512 | 49.4% |
| Joint dislocationa dislocated joint | 56 | 5.4% |
| Joint laxity | 33 | 3.2% |
| Aseptic loosening | 29 | 2.8% |
| Periprosthetic fracture | 20 | 1.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 19 | 1.8% |
| Implant pain | 10 | 1% |
| Falla fall | 9 | 0.9% |
| Limb pain | 9 | 0.9% |
| Bone fracture(s) | 8 | 0.8% |
| Fungal infectiona fungal infection | 6 | 0.6% |
| Painpain, site not specified | 6 | 0.6% |
| Failure of implant | 5 | 0.5% |
| Limb fracture | 4 | 0.4% |
| Scar tissue | 3 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | ELEOS Limb Salvage System | Product code KRO | All MAUDE reports |
|---|---|---|---|
| Reports | 1,037 | 9,412 | 26,136,888 |
| Share of that pool | — | 11% | 0% |
| Classified as death, per 1,000 reports | 9 | 6 | 9 |
| Classified as injury | 98.3% | 88.7% | 36.2% |
| Classified as malfunction | 0.9% | 10.5% | 62.3% |
| Filed by the manufacturer | 100% | 97.5% | 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 KRO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Eleos | 991 | 2 | 0.1% |
| Unknown Femoral Component | 642 | 90 | 0.3% |
| Unknown Stryker knee | 194 | 17 | 0.5% |
| Unknown Knee | 1,847 | 18 | 1.5% |
| Unknown Articular Surface | 473 | 78 | 0% |
| Nexgen Stemmed Tibial Component | 408 | 0 | 0% |
| Pfc Sigma/Ov Dome Pat 3 Peg 32 | 232 | 0 | 0% |
| Series 7000 Standard Tibia | 293 | 0 | 0% |
| Sig Mod Tib Tray Cem Cocr 4 | 319 | 2 | 0.3% |
| Simplex P-Japanese Twin Pack | 312 | 1 | 10.6% |
| Sp2 Tibial Radel Impactor | 1,039 | 2 | 0% |
| Tibial Articular Surface Provisional Left Size Gh | 252 | 0 | 0% |
| Triathlon Ps X3 Tibial Insert | 1,106 | 21 | 0% |
| Unknown Bearing | 317 | 84 | 0.3% |
| Unknown NexGen Articular Surface | 243 | 26 | 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 ELEOS Limb Salvage System reports
How many FDA reports name ELEOS Limb Salvage System?
1,037 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 453 in the latest 12 months.
What kinds of events are reported?
injury (98.3%), death (0.9%) and malfunction (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (7.2%), device appears to trigger rejection (2.4%), patient device interaction problem (2.1%), loosening of implant not related to bone-ingrowth (1.9%) and patient-device incompatibility (1.9%). 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 ELEOS Limb Salvage System 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.