Devices › Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Device brand name · Prosthesis knee patello/femorotibial semi-constrained uncemented porous co
Triathlon Ps X3 Tibial Insert: medical device reports filed with FDA
1,106 reports name it, 2007–2026. Manufacturer given most often on reports: Stryker Orthopaedics-Mahwah. Product code MBH.
- 1,106
- device reports naming the brand
- 0% of all MAUDE reports · about 58 a year
- 21
- reports, 12 months to August 2026
- 51 in the 12 months before
- 12.9%
- classified as malfunction
- 24% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,106 medical device reports received by FDA name the brand "Triathlon Ps X3 Tibial Insert" (prosthesis knee patello/femorotibial semi-constrained uncemented porous co); the manufacturer given most often on reports is Stryker Orthopaedics-Mahwah; received from June 2007 to May 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
21 reports arrived in the 12 months to August 2026, down 59% from 51 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 (86.8%), malfunction (12.9%) and other (0.3%); across all prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer reports (product code MBH) death is recorded in 0.1% and malfunction in 24%. 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 (42%), unstable (15.6%) and device operates differently than expected (3.7%). The patient problems coded most often are injury, pain and ambulation or postural difficulties. 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 16,482 reports carrying product code MBH. 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 | 465 | 42% | 19.2% |
| Unstable | 172 | 15.6% | 9.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 41 | 3.7% | 1.5% |
| Device slipped | 24 | 2.2% | 1.2% |
| Mechanical problema mechanical problem | 24 | 2.2% | 1.5% |
| Breakthe device broke | 23 | 2.1% | 5.5% |
| Fracturea broken bone | 23 | 2.1% | 9.8% |
| Difficult to insertthe device was hard to insert | 21 | 1.9% | 2.1% |
| Noise, audible | 21 | 1.9% | 1.2% |
| Positioning problem | 19 | 1.7% | 0.4% |
| Fitting problem | 18 | 1.6% | 0.6% |
| Detachment of device or device componentpart of the device came off | 15 | 1.4% | 2.1% |
| Device dislodged or dislocated | 14 | 1.3% | 1.6% |
| Inadequacy of device shape and/or size | 13 | 1.2% | 0.6% |
| Naturally worn | 12 | 1.1% | 2% |
| Material deformation | 11 | 1% | 0.8% |
| Detachment of device component | 10 | 0.9% | 0.4% |
| Loose or intermittent connection | 9 | 0.8% | 1.5% |
| Degraded | 8 | 0.7% | 1.3% |
| Device difficult to setup or prepare | 7 | 0.6% | 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 |
|---|---|---|
| Injurya physical injury | 344 | 31.1% |
| Painpain, site not specified | 233 | 21.1% |
| Ambulation or postural difficulties | 90 | 8.1% |
| Loss of range of motion | 55 | 5% |
| Joint laxity | 49 | 4.4% |
| Falla fall | 41 | 3.7% |
| Swellingswelling | 30 | 2.7% |
| Limited mobility of the implanted joint | 17 | 1.5% |
| Inflammationinflammation | 11 | 1% |
| Scar tissue | 10 | 0.9% |
| Discomfortdiscomfort | 9 | 0.8% |
| Bacterial infectiona bacterial infection | 8 | 0.7% |
| Swelling/ edema | 8 | 0.7% |
| Adhesion(s) | 7 | 0.6% |
| Fibrosis | 7 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Triathlon Ps X3 Tibial Insert | Product code MBH | All MAUDE reports |
|---|---|---|---|
| Reports | 1,106 | 16,482 | 26,136,888 |
| Share of that pool | — | 6.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 86.8% | 75.7% | 36.2% |
| Classified as malfunction | 12.9% | 24% | 62.3% |
| Filed by the manufacturer | 100% | 99.5% | 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 MBH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Triathlon Cr X3 Tibial Insert | 723 | 13 | 0% |
| Unknown Knee | 1,847 | 18 | 1.5% |
| Triathlon Prim Tib Baseplate - Cemented | 384 | 3 | 0.5% |
| Triathlon Ps Fem Component Cemented | 298 | 6 | 0.3% |
| Triathlon Asymmetric X3 Patella | 171 | 6 | 0% |
| Persona FEMORAL CR IMPACTOR PAD | 348 | 33 | 0% |
| Nexgen Lps-Flex Prolong Articular Surface | 161 | 0 | 0% |
| Unknown Stryker knee | 194 | 17 | 0.5% |
| Femoral Cr Impactor Pad | 381 | 12 | 0% |
| Tibial Articular Surface Provisional Left Size Ef | 422 | 0 | 0% |
| Nexgen Cr-Flex Femoral Component | 251 | 0 | 0% |
| Tibial Articular Surface Provisional Right Size Ef | 425 | 0 | 0% |
| Unknown Femoral Component | 642 | 90 | 0.3% |
| R3 Offset Impactor Tip | 497 | 44 | 0% |
| Unknown Articular Surface | 473 | 78 | 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 Triathlon Ps X3 Tibial Insert reports
How many FDA reports name Triathlon Ps X3 Tibial Insert?
1,106 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 21 in the latest 12 months.
What kinds of events are reported?
injury (86.8%), malfunction (12.9%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (42%), unstable (15.6%), device operates differently than expected (3.7%), device slipped (2.2%) and mechanical problem (2.2%). 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 Triathlon Ps X3 Tibial Insert 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.