Devices › Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Device brand name · Sigma knee primary knee tibial insert
Pfc Sigmarp Stb Tb In 4 10 0: medical device reports filed with FDA
328 reports name it, 2005–2025. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code NJL.
- 328
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 5
- reports, 12 months to August 2026
- 8 in the 12 months before
- 0.6%
- classified as malfunction
- 3.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 328 reports that name the brand "Pfc Sigmarp Stb Tb In 4 10 0" (sigma knee primary knee tibial insert), received between June 2005 and December 2025; the manufacturer given most often on reports is Depuy Orthopaedics US. Spellings of one product vary from report to report.
5 reports arrived in the 12 months to August 2026, down 37% 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 (99.4%) and malfunction (0.6%); 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 (42.4%), implant, removal of (11.9%) and naturally worn (10.7%). The patient problems coded most often are pain, osteolysis and loss of range of motion. 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 | 139 | 42.4% | 19.8% |
| Implant, removal of | 39 | 11.9% | 7% |
| Naturally worn | 35 | 10.7% | 5.8% |
| Component(s), worn | 8 | 2.4% | 1.4% |
| Other (for use when an appropriate device code cannot be identified) | 4 | 1.2% | 0.8% |
| Breakthe device broke | 2 | 0.6% | 0.8% |
| Fracturea broken bone | 2 | 0.6% | 0.9% |
| Malposition of device | 2 | 0.6% | 1% |
| Off-label use | 2 | 0.6% | 0.2% |
| Unintended movement | 2 | 0.6% | 0.9% |
| Unstable | 2 | 0.6% | 0.2% |
| Device dislodged or dislocated | 1 | 0.3% | 0.9% |
| Loose | 1 | 0.3% | 2.2% |
| Loss of or failure to bond | 1 | 0.3% | 18.4% |
| Membrane leak(s) | 1 | 0.3% | 0% |
| Missing information | 1 | 0.3% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.3% | 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 |
|---|---|---|
| Painpain, site not specified | 124 | 37.8% |
| Osteolysis | 21 | 6.4% |
| Loss of range of motion | 10 | 3% |
| Ambulation or postural difficulties | 5 | 1.5% |
| Discomfortdiscomfort | 5 | 1.5% |
| Adhesion(s) | 4 | 1.2% |
| Joint laxity | 4 | 1.2% |
| Joint swellinga swollen joint | 4 | 1.2% |
| Muscular rigidity | 4 | 1.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 0.9% |
| Edemaswelling from fluid | 3 | 0.9% |
| Falla fall | 2 | 0.6% |
| Inflammationinflammation | 2 | 0.6% |
| Limited mobility of the implanted joint | 2 | 0.6% |
| Swellingswelling | 2 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pfc Sigmarp Stb Tb In 4 10 0 | Product code NJL | All MAUDE reports |
|---|---|---|---|
| Reports | 328 | 26,046 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 99.4% | 96.8% | 36.2% |
| Classified as malfunction | 0.6% | 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% |
| Nexgen Lps-Flex Femoral Component | 502 | 0 | 0% |
| Mbt Cem Keel Tib Tray Sz2 | 296 | 3 | 0% |
| Pfc Sigmarp Stb Tb In 3 10 0 | 302 | 2 | 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 4 10 0 reports
How many FDA reports name Pfc Sigmarp Stb Tb In 4 10 0?
328 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5 in the latest 12 months.
What kinds of events are reported?
injury (99.4%) and malfunction (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (42.4%), implant, removal of (11.9%), naturally worn (10.7%), component(s), worn (2.4%) and other (for use when an appropriate device code cannot be identified) (1.2%). 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 Pfc Sigmarp Stb Tb In 4 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.