Devices › Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Device brand name · Sigma knee primary knee tibial insert
Pfc Sigmarp Stb Tb In 3 10 0: medical device reports filed with FDA
302 reports name it, 2005–2025. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code NJL.
- 302
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 2
- reports, 12 months to August 2026
- 8 in the 12 months before
- 0%
- classified as malfunction
- 3.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
302 medical device reports received by FDA name the brand "Pfc Sigmarp Stb Tb In 3 10 0" (sigma knee primary knee tibial insert); the manufacturer given most often on reports is Depuy Orthopaedics US; received from April 2005 to November 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
2 reports arrived in the 12 months to August 2026, down 75% from 8 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 (100%); across all prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing reports (product code NJL) death is recorded in 0% and malfunction in 3.2%. 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 (43.7%), naturally worn (11.3%) and implant, removal of (5%). The patient problems coded most often are pain, osteolysis and not applicable. 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 26,046 reports carrying product code NJL. 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 | 132 | 43.7% | 19.8% |
| Naturally worn | 34 | 11.3% | 5.8% |
| Implant, removal of | 15 | 5% | 7% |
| Component(s), worn | 6 | 2% | 1.4% |
| Loss of or failure to bond | 3 | 1% | 18.4% |
| Noise, audible | 2 | 0.7% | 0.6% |
| Component incompatible | 1 | 0.3% | 0% |
| Device dislodged or dislocated | 1 | 0.3% | 0.9% |
| Inadequacy of device shape and/or size | 1 | 0.3% | 0.5% |
| Other (for use when an appropriate device code cannot be identified) | 1 | 0.3% | 0.8% |
| Unintended movement | 1 | 0.3% | 0.9% |
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 | 113 | 37.4% |
| Osteolysis | 22 | 7.3% |
| Not applicable | 5 | 1.7% |
| Joint laxity | 4 | 1.3% |
| Muscular rigidity | 4 | 1.3% |
| Loss of range of motion | 3 | 1% |
| Discomfortdiscomfort | 2 | 0.7% |
| Joint swellinga swollen joint | 2 | 0.7% |
| Limited mobility of the implanted joint | 2 | 0.7% |
| Ambulation or postural difficulties | 1 | 0.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.3% |
| Cyst(s) | 1 | 0.3% |
| Failure of implant | 1 | 0.3% |
| Falla fall | 1 | 0.3% |
| Fatiguetiredness | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pfc Sigmarp Stb Tb In 3 10 0 | Product code NJL | All MAUDE reports |
|---|---|---|---|
| Reports | 302 | 26,046 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 100% | 96.8% | 36.2% |
| Classified as malfunction | 0% | 3.2% | 62.3% |
| Filed by the manufacturer | 100% | 99.8% | 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 NJL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Mbt Cem Keel Tib Tray Sz3 | 1,085 | 9 | 0% |
| Mbt Cem Keel Tib Tray Sz4 | 655 | 4 | 0% |
| Mbt Cem Keel Tib Tray Sz2 5 | 643 | 6 | 0% |
| Attune Rp Tib Base Sz 5 Cem | 613 | 7 | 0% |
| Attune Rp Tib Base Sz 4 Cem | 603 | 7 | 0% |
| Attune Rp Tib Base Sz 7 Cem | 409 | 7 | 0% |
| Attune Rp Tib Base Sz 6 Cem | 388 | 14 | 0.3% |
| Mbt Cem Keel Tib Tray Sz5 | 371 | 3 | 0% |
| Pfc Sigmarp Stb Tb In 4 10 0 | 328 | 5 | 0% |
| Nexgen Lps-Flex Femoral Component | 502 | 0 | 0% |
| Mbt Cem Keel Tib Tray Sz2 | 296 | 3 | 0% |
| Attune Rp Tib Base Sz 8 Cem | 269 | 4 | 0% |
| Unknown Knee Tibial Insert | 2,247 | 130 | 0.2% |
| Attune Rp Tib Base Sz 3 Cem | 272 | 2 | 0% |
| Lcs Comp Rp Insert Lg 10mm | 241 | 1 | 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 Pfc Sigmarp Stb Tb In 3 10 0 reports
How many FDA reports name Pfc Sigmarp Stb Tb In 3 10 0?
302 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2 in the latest 12 months.
What kinds of events are reported?
injury (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (43.7%), naturally worn (11.3%), implant, removal of (5%), component(s), worn (2%) and loss of or failure to bond (1%). 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 Pfc Sigmarp Stb Tb In 3 10 0 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.