Devices › Prosthesis, shoulder, non-constrained, metal/polymer cemented
Device brand name · Prosthesis shoulder non-constrained metal/polymer cemented
Equinoxe: medical device reports filed with FDA
1,251 reports name it, 2010–2026. Manufacturer given most often on reports: Exactech. Product code KWT.
- 1,251
- device reports naming the brand
- 0% of all MAUDE reports · about 79 a year
- 108
- reports, 12 months to August 2026
- 75 in the 12 months before
- 9.8%
- classified as malfunction
- 12.5% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 1,251 reports that name the brand "Equinoxe" (prosthesis shoulder non-constrained metal/polymer cemented), received between October 2010 and July 2026; the manufacturer given most often on reports is Exactech. Spellings of one product vary from report to report.
108 reports arrived in the 12 months to August 2026, up 44% from 75 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 (82.7%), malfunction (9.8%) and other (7.4%); across all prosthesis, shoulder, non-constrained, metal/polymer cemented reports (product code KWT) death is recorded in 0.2% and malfunction in 12.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device dislodged or dislocated (17.7%), break (14.3%) and loosening of implant not related to bone-ingrowth (9.5%). The patient problems coded most often are failure of implant, joint dislocation 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
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 5,693 reports carrying product code KWT. 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 |
|---|---|---|---|
| Device dislodged or dislocated | 221 | 17.7% | 16.4% |
| Breakthe device broke | 179 | 14.3% | 3.8% |
| Loosening of implant not related to bone-ingrowth | 119 | 9.5% | 6% |
| Fracturea broken bone | 88 | 7% | 7.8% |
| Detachment of device or device componentpart of the device came off | 73 | 5.8% | 8.5% |
| Loose or intermittent connection | 53 | 4.2% | 4% |
| Insufficient device problem information | 52 | 4.2% | 10.6% |
| Naturally worn | 46 | 3.7% | 7.2% |
| Unstable | 39 | 3.1% | 5.1% |
| Device slipped | 29 | 2.3% | 1.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 0.8% | 1% |
| Migrationthe device moved from where it was placed | 10 | 0.8% | 1.4% |
| Lack of effect | 8 | 0.6% | 0.5% |
| Improper or incorrect procedure or method | 7 | 0.6% | 0.5% |
| Positioning problem | 7 | 0.6% | 0.2% |
| Material separation | 6 | 0.5% | 0.6% |
| Inadequacy of device shape and/or size | 5 | 0.4% | 0.5% |
| Patient-device incompatibilitythe device did not suit the patient | 5 | 0.4% | 0.3% |
| Malposition of device | 4 | 0.3% | 0.4% |
| Mechanical jam | 4 | 0.3% | 0.4% |
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 |
|---|---|---|
| Failure of implant | 247 | 19.7% |
| Joint dislocationa dislocated joint | 158 | 12.6% |
| Painpain, site not specified | 127 | 10.2% |
| Bacterial infectiona bacterial infection | 109 | 8.7% |
| Bone fracture(s) | 60 | 4.8% |
| Falla fall | 29 | 2.3% |
| Osteolysis | 26 | 2.1% |
| Loss of range of motion | 24 | 1.9% |
| Joint laxity | 23 | 1.8% |
| Device embedded in tissue or plaque | 21 | 1.7% |
| Aseptic loosening | 20 | 1.6% |
| Metal related pathology | 19 | 1.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 11 | 0.9% |
| Implant pain | 11 | 0.9% |
| Muscle/tendon damage | 11 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Equinoxe | Product code KWT | All MAUDE reports |
|---|---|---|---|
| Reports | 1,251 | 5,693 | 26,136,888 |
| Share of that pool | — | 22% | 0% |
| Classified as death, per 1,000 reports | 1 | 2 | 9 |
| Classified as injury | 82.7% | 85.7% | 36.2% |
| Classified as malfunction | 9.8% | 12.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.2% | 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 KWT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Equinoxe Reverse Shoulder Components | 440 | 200 | 0% |
| Specific Device Not Reported | 1,462 | 20 | 0.2% |
| Equinoxe Reverse Humeral Adapter Tray | 161 | 0 | 0% |
| Equinoxe Reverse Humeral Liner | 173 | 0 | 0% |
| SMR Shoulder | 257 | 161 | 0% |
| Modular Center Post Reamer | 173 | 21 | 0% |
| Screw | 647 | 0 | 0% |
| Unknown Extremity | 155 | 0 | 1.9% |
| Comp Rvrs 25mm Bsplt Ha+adptr | 239 | 17 | 0% |
| Exactech | 576 | 0 | 0% |
| Unk head | 405 | 146 | 0.5% |
| Unk Reamer | 833 | 71 | 0% |
| Unknown Knee Components | 312 | 42 | 0.3% |
| Unknown Shoulder Humeral Stems | 239 | 8 | 1.7% |
| Unknown Shoulder Implant | 254 | 8 | 0.8% |
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 Equinoxe reports
How many FDA reports name Equinoxe?
1,251 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 108 in the latest 12 months.
What kinds of events are reported?
injury (82.7%), malfunction (9.8%) and other (7.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (17.7%), break (14.3%), loosening of implant not related to bone-ingrowth (9.5%), fracture (7%) and detachment of device or device component (5.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Equinoxe 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.