Devices › Prosthesis, knee, hemi-, tibial, resurfacing (uncemented)
Device brand name · Tibial insert
Foundation Knee System: medical device reports filed with FDA
371 reports name it, 2001–2010. Manufacturer given most often on reports: Encore Medical L P. Product code HSH.
- 371
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 3.8%
- classified as malfunction
- 13.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
371 medical device reports received by FDA name the brand "Foundation Knee System" (tibial insert); the manufacturer given most often on reports is Encore Medical L P; received from April 2001 to July 2010. 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 other (84.4%), injury (11.9%) and malfunction (3.8%); across all prosthesis, knee, hemi-, tibial, resurfacing (uncemented) reports (product code HSH) death is recorded in 0.1% and malfunction in 13.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are explanted (51.5%), replace (25.6%) and break (20.8%). The patient problems coded most often are surgical procedure, repeated, surgical procedure 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 Foundation Knee System was received in the five years to August 2026; the latest was received in July 2010.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,111 reports carrying product code HSH. 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 |
|---|---|---|---|
| Explanted | 191 | 51.5% | 46.3% |
| Replace | 95 | 25.6% | 26.1% |
| Breakthe device broke | 77 | 20.8% | 3.6% |
| Insufficient device problem information | 40 | 10.8% | 3.4% |
| Component(s), worn | 25 | 6.7% | 16.7% |
| Naturally worn | 24 | 6.5% | 2.5% |
| Loose | 21 | 5.7% | 17.5% |
| Device slipped | 17 | 4.6% | 1.7% |
| Unstable | 17 | 4.6% | 0.9% |
| Component(s), broken | 15 | 4% | 1.5% |
| Inadequacy of device shape and/or size | 13 | 3.5% | 0.5% |
| Fracturea broken bone | 11 | 3% | 2.6% |
| Device dislodged or dislocated | 7 | 1.9% | 0.4% |
| Device issuea problem with the device | 6 | 1.6% | 1.5% |
| Fitting problem | 6 | 1.6% | 4.2% |
| Mechanical problema mechanical problem | 4 | 1.1% | 0.3% |
| Patient-device incompatibilitythe device did not suit the patient | 4 | 1.1% | 0% |
| Other (for use when an appropriate device code cannot be identified) | 3 | 0.8% | 2.7% |
| Collapse | 2 | 0.5% | 0.2% |
| Component missing | 2 | 0.5% | 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 |
|---|---|---|
| Surgical procedure, repeated | 127 | 34.2% |
| Surgical procedure | 75 | 20.2% |
| Painpain, site not specified | 47 | 12.7% |
| Hospitalization required | 17 | 4.6% |
| Loss of range of motion | 15 | 4% |
| Falla fall | 12 | 3.2% |
| Inflammationinflammation | 12 | 3.2% |
| Swellingswelling | 7 | 1.9% |
| Other (for use when an appropriate patient code cannot be identified) | 6 | 1.6% |
| Fluid discharge | 4 | 1.1% |
| Hypersensitivity/allergic reaction | 4 | 1.1% |
| Scar tissue | 4 | 1.1% |
| Tissue damage | 4 | 1.1% |
| Ambulation or postural difficulties | 3 | 0.8% |
| Bone fracture(s) | 2 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Foundation Knee System | Product code HSH | All MAUDE reports |
|---|---|---|---|
| Reports | 371 | 8,111 | 26,136,888 |
| Share of that pool | — | 4.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 11.9% | 80.6% | 36.2% |
| Classified as malfunction | 3.8% | 13.3% | 62.3% |
| Filed by the manufacturer | 100% | 89.7% | 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 HSH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Depuy Insert | 520 | 0 | 0% |
| Unknown Depuy Tibial Tray | 633 | 0 | 0% |
| Unknown Depuy Tibial Insert | 728 | 0 | 0% |
| Zimmer | 1,159 | 0 | 2.8% |
| Unk Depuy Insert | 191 | 0 | 0% |
| Genesis | 1,648 | 0 | 0.1% |
| Series 7000 Standard Tibia | 293 | 0 | 0% |
| Journey | 256 | 0 | 0% |
| Optetrak | 710 | 15 | 0% |
| Biomet | 337 | 0 | 0.3% |
| Triathlon Cr X3 Tibial Insert | 723 | 13 | 0% |
| Mbt Cem Keel Tib Tray Sz3 | 1,085 | 9 | 0% |
| Pca Knee | 165 | 0 | 0% |
| Triathlon Ps X3 Tibial Insert | 1,106 | 21 | 0% |
| Profix | 823 | 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 Foundation Knee System reports
How many FDA reports name Foundation Knee System?
371 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?
other (84.4%), injury (11.9%) and malfunction (3.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (51.5%), replace (25.6%), break (20.8%), insufficient device problem information (10.8%) and component(s), worn (6.7%). 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 Foundation Knee 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.