Devices › Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Device brand name · Sigma revision implant knee femoral accessory
Sig Fem Adap +2/-2 Offset Bolt: medical device reports filed with FDA
252 reports name it, 2010–2025. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code JWH.
- 252
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 7
- reports, 12 months to August 2026
- 7 in the 12 months before
- 1.6%
- classified as malfunction
- 14.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
252 medical device reports received by FDA name the brand "Sig Fem Adap +2/-2 Offset Bolt" (sigma revision implant knee femoral accessory); the manufacturer given most often on reports is Depuy Orthopaedics US; received from May 2010 to December 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
7 reports arrived in the 12 months to August 2026, close to the 7 of 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 (98.4%) and malfunction (1.6%); across all prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer reports (product code JWH) death is recorded in 0.2% and malfunction in 14.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fracture (23%), insufficient device problem information (13.5%) and break (9.1%). The patient problems coded most often are pain, joint laxity and appropriate clinical signs, symptoms and conditions term/code not available. 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 158,133 reports carrying product code JWH. 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 |
|---|---|---|---|
| Fracturea broken bone | 58 | 23% | 7.3% |
| Insufficient device problem information | 34 | 13.5% | 18.1% |
| Breakthe device broke | 23 | 9.1% | 3.9% |
| Device dislodged or dislocated | 11 | 4.4% | 1.7% |
| Noise, audible | 5 | 2% | 1% |
| Loss of or failure to bond | 3 | 1.2% | 6.3% |
| Loss of osseointegration | 2 | 0.8% | 0.9% |
| Malposition of device | 2 | 0.8% | 0.9% |
| Defective devicethe device was defective | 1 | 0.4% | 0.1% |
| Degraded | 1 | 0.4% | 0.2% |
| Device-device incompatibility | 1 | 0.4% | 0.1% |
| Loose or intermittent connection | 1 | 0.4% | 2.1% |
| Material separation | 1 | 0.4% | 0.1% |
| Migrationthe device moved from where it was placed | 1 | 0.4% | 0.8% |
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 | 95 | 37.7% |
| Joint laxity | 17 | 6.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 15 | 6% |
| Adhesion(s) | 9 | 3.6% |
| Edemaswelling from fluid | 8 | 3.2% |
| Swelling/ edema | 8 | 3.2% |
| Foreign body reaction | 7 | 2.8% |
| Loss of range of motion | 6 | 2.4% |
| Falla fall | 5 | 2% |
| Discomfortdiscomfort | 4 | 1.6% |
| Hypersensitivity/allergic reaction | 4 | 1.6% |
| Muscular rigidity | 4 | 1.6% |
| Synovitis | 4 | 1.6% |
| Ambulation or postural difficulties | 3 | 1.2% |
| Fatiguetiredness | 3 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sig Fem Adap +2/-2 Offset Bolt | Product code JWH | All MAUDE reports |
|---|---|---|---|
| Reports | 252 | 158,133 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 98.4% | 84.1% | 36.2% |
| Classified as malfunction | 1.6% | 14.7% | 62.3% |
| Filed by the manufacturer | 100% | 98.4% | 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 JWH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Knee Tibial Insert | 2,247 | 130 | 0.2% |
| Unknown Knee Femoral | 1,897 | 65 | 0.2% |
| Unknown Knee Tibial Tray | 1,958 | 57 | 0.2% |
| Persona Tibial Articular Surface Provisional | 1,584 | 0 | 0% |
| Itotal G2 | 1,250 | 0 | 0% |
| Specific Device Not Reported | 1,462 | 20 | 0.2% |
| Apex Knee System | 1,001 | 49 | 0% |
| Djo Surgical | 4,713 | 2,448 | 0% |
| Unknown Knee | 1,847 | 18 | 1.5% |
| Attune Fb Tib Base Sz 5 Cem | 863 | 18 | 0% |
| Attune Fb Tib Base Sz 4 Cem | 797 | 14 | 0% |
| Pfc Sigma/Ov/Dome Pat 3peg 38 | 806 | 3 | 0.4% |
| Unknown Knee Patella | 791 | 26 | 0.4% |
| Unknown Reconstructive Product | 2,579 | 0 | 0.4% |
| UNK Attune Knee Tibial Insert | 895 | 102 | 0.1% |
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 Sig Fem Adap +2/-2 Offset Bolt reports
How many FDA reports name Sig Fem Adap +2/-2 Offset Bolt?
252 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 7 in the latest 12 months.
What kinds of events are reported?
injury (98.4%) and malfunction (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (23%), insufficient device problem information (13.5%), break (9.1%), device dislodged or dislocated (4.4%) and noise, audible (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 Sig Fem Adap +2/-2 Offset Bolt 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.